Sr Energy Solutions Specialist

Nextera Energy, Inc Naples , FL 34102

Posted 2 months ago

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Requisition ID: 49791

Our reliability is one of the best in the nation, and we're working to make it even better. We live here too.

That's why we're committed to making Florida a better place. Join our team today Learn more

Position Specific Description

Florida Power & Light Company (FPL) is the largest rate regulated utility company in the United States serving more than five million customer accounts across the state of Florida. FPL is a subsidiary of NextEra Energy, Inc., headquartered in Juno Beach, FL, a clean energy company widely recognized for its efforts in sustainability, ethics and diversity.

Florida Power & Light Company's Customer Solutions & Field Experience Department is seeking a Sr. Energy Solutions Specialist to join their team.

This position can be filled at any one of our facilities located in Punta Gorda, Fort Myers or Naples, FL. A candidate with a Bachelor's Degree is highly preferred.

We look forward to taking your career to the next level!

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Sr Supplier QA Specialist

Arthrex, Inc.

Posted 3 weeks ago

VIEW JOBS Requisition ID: 47703 Title: Sr - Supplier QA Specialist Division: Arthrex, Inc. (US01) Location: Naples, FL Main Objective: To manage and maintain Arthrex supplier base to assure products and processes, internally and externally, meet specifications, while improving supplier product quality performance through PPAP and supplier collaboration, and supplier process validations in support of development and manufacturing of Class I, II and III medical devices. Essential Duties and Responsibilities: * Responsible for initiating PPAPs and reviewing Supplier Part Submission Warrant (PSW) documents (pFMEA, Process Flow Diagrams, Process Control Plans, Measurement System Analysis (Gage R&R), Dimensional Results (FAIR), Capability Studies, Material Analysis Records, etc.) to ensure compliance to applicable standards (ISO 13485, ISO 17025, ISO 11737, etc.), regulations (21 CFR Part 820, EU MDR, etc.) and internal procedures. * Collaborate with business partners and suppliers to assist, in writing, executing, and approving IQ/OQ/PQ protocols and conducting process validations of special processes, including machining, electropolishing, anodizing, laser welding, molding, etc. * Responsible for reviewing Supplier Change Requests (SCR) and Supplier Proposed Process Changes (SPPC) to ensure continuous compliance to applicable standards, regulation and internal procedures. * Assist in the design and development of methods and tooling for the test and inspection of articles including conducting Gage R&R activities and Capability Studies. * Develop and revise new and existing internal and external supplier validation procedures, work instructions, and forms to insure compliance to cGMP, standards, and regulatory requirements. * Responsible for and assisting in compiling and reporting on supplier performance metrics / statistics and supplier development activities. * Evaluate and determine reduced or increased inspection plans based on supplier performance and controls. * Lead / participate with suppliers in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA). * Lead / participate with business and/or supplier partners toward improvement / development of Arthrex processes. * Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, Impact Assessments and other Quality Systems. * This role may supervise Global Supplier Quality department personnel. * This role may require travel up to 25% of the time. Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Education and Experience: * Bachelor's degree required preferably in a Technical, Business, or Science discipline * 9 years of Supplier Quality work experience required, preferably within a Medical Device Company Knowledge and Skill Requirements/Specialized Courses and/or Training: Knowledge of testing equipment, statistical methods, control plans, FMEA, Gage R&R and other MSA methodologies. Knowledge of FAI / PPAP requirements Knowledge of cGMP, ISO 13485, Regulatory, and GDP requirements. Machine, Tools, and/or Equipment Skills: Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software, and MiniTab. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Sr Biological Safety Specialist

Arthrex, Inc.

Posted 2 months ago

VIEW JOBS Requisition ID: 47538 Title: Biological Safety Specialist Sr Division: Arthrex, Inc. (US01) Location: Naples, FL Main Objective: Maintain Arthrex, Inc.'s biological safety projects in accordance with Quality Systems Requirements. Essential Duties and Responsibilities: * Develop and manage internal programs, with a global perspective, on biological safety risk assessment, testing plans / strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirement; * Participate in design review meetings as a key member of new product design teams to assess products for biocompatibility and related biological safety concerns, including documentation of biological safety assessments, test plans, and associated reports; * Actively represent Arthrex and the medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT; * Manage the appropriate maintenance, review, and gap analysis / impact assessment of external standards, regulatory requirements, and guidance's associated with biological safety; * Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex's global laboratory service providers in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives; * Mentor teams, share experience, and provide best practices to biological safety / quality staff related to biological safety systems, corporate policy, and regulatory requirement; * Encourage and foster an environment based upon a foundation of continuous process improvement and industry benchmarking; * Support and lead Arthrex's business and expansion goals; * Must be able to travel domestically and internationally up to 15% of the time Knowledge: Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices. Reasoning Ability: Develops solutions to a variety of complex problems. May refer to established precedents and policies. Discretion/ Latitude: Work is performed under general direction. Participates in determining objectives of assignment. Plans schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives. Skills: Work is performed under general direction. Participates in determining objectives of assignment. Plans schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives. * Knowledgeable of FDA and ISO guidelines for the biocompatibility assessment of medical devices required. * Manufacturing process knowledge preferred. * Project management and communication skills training preferred. * Working knowledge of biocompatibility test systems requirements. * Hands on experience managing laboratory testing activities. * Test protocol and report writing experience preferred. * Working knowledge of device clinical use and associated harms and hazards * Knowledge of orthopedic surgery principles, theories, and products preferred. * Personnel supervision experience preferred Education/ Experience: * 7 Years' experience in an FDA /ISO regulated environment * BS Degree in Engineering, biology/microbiology, chemistry, toxicology or related science field * MS Preferred * Previous project leadership experience required * Experience in project management, risk management (such as FMEA, FTA, FMECA) tools are highly desirable. * Experience in working with Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting required. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Regulatory Affairs Specialist I

Arthrex, Inc.

Posted 4 days ago

VIEW JOBS Requisition ID: 48018 Title: Regulatory Affairs Specialist I Division: Arthrex, Inc. (US01) Location: INC - Arthrex One (US33) Main Objective: Responsible for managing specific aspects of the Arthrex Regulatory Affairs program with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts. In coordination with management of Regulatory Affairs, this role will develop regulatory strategy, execute the regulatory plan, and perform other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices. Essential Duties and Responsibilities: * Develop regulatory strategies and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status. * May evaluate the risk of proposed regulatory strategies and offer solutions as applicable. * Advise project teams on premarket regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues. * Provide project teams with on-going support to resolve any real or perceived regulatory issues. * Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes * Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. * Coordinate, prepare, write, submit and/or review regulatory submissions for projects in accordance with established product launch or other applicable timelines. * Coordinate efforts with regional counterparts associated with the preparation of international regulatory documents or submissions. * Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. * Review and approve design control documentation, engineering change requests, manufacturing and labeling changes, and other applicable requests for adherence to global regulatory compliance. * Review and approve product advertising/promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies. * Review or edit regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability. * Communicate with regulatory agencies with or without direction regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. * Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. * Establish, develop and maintain positive relationships with regulatory agency personnel. * Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products. * Maintain current knowledge base of existing and emerging regulations, standards, and/or guidance documents. * Explain regulations, guidance's, policies, and/or procedures to stakeholders, as applicable. * Review clinical protocols to ensure collection of data is sufficient for regulatory submissions. * Recommend changes to company procedures in response to changes in regulations, guidance's and/or standards. * Obtain and distribute updated information regarding domestic or international laws, guidance's and/or standards. * Write or update standard operating procedures, work instructions, or policies. * Participate in internal or external audits, as required. * May develop or conduct employee regulatory training Problem Solving Develops solutions to routine technical problems of limited scope. Discretion/Latitude Work is closely supervised. Follows specific detailed instructions. Impact Contributes to completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Liaison Contacts are primarily with immediate supervisor, project leaders, and other professionals in the section or group. Knowledge * Limited use and/or application of technical principles, theories, and concepts. * Basic knowledge of regulatory framework and regulatory requirements for one region. * Basic knowledge of human physiology/anatomy and associated medical terminology. * Basic knowledge of orthopedic terminology, surgery principles, theories and products. * Basic knowledge of current medical device regulations, standards, guidance's and regulatory requirements for medical devices in region of specialization. * Basic knowledge of 21 CFR 820/ISO 13485. * Basic knowledge of product lifecycle, product development process, design control and change control. * Basic knowledge of clinical trial strategy and study design, and sponsor reporting requirements. Education/Experience * Experience in a regulatory affairs role in the life science industry preferred. * Bachelor's degree preferred, engineering or science discipline preferred. * Advanced degree preferred. * Orthopedic medical device experience preferred. * Regulatory Affairs Certification (RAC) preferred. * Regulatory submission experience preferred. Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Reasoning Ability: Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making. Abilities Requirements: Ability to comprehend principles of engineering, physiology and medical device use. Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that make sense. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment. Machine, Tools, and/or Equipment Skills: Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company). Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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