Manager, Regulatory And Quality Systems

Benchmark Electronics Fremont , CA 94537

Posted 2 months ago

Precision Technologies, a division of Benchmark Electronics, Inc.Precision Technologies Fremont has an extensive capability in mechanical manufacturing. Our customers are leading Original Equipment Manufacturers who require exacting precision mechanical production capabilities.

Our product lines include the, Aerospace, Healthcare Scientific Instrumentation, and complex electro-mechanical equipment. Our Capabilities Include: Precision CNC 5-Axis Milling and Turning Precision 5-Axis Grinding of Aerospace Turbine Engine Nozzles and Blades Close Tolerance (Micron level) Instrumentation Grinding Electrical Discharge Machining (EDM) NADCAP approved Complex Electro-Mechanical assembly and test (Class 1K & 10K clean room) Functional testing Medium to Large Coordinate Measuring CapabilitiesThe Manager of Quality and Regulatory Systems will Manage Quality Systems Support by developing, implementing, and maintaining current and future Product/Process Inspection and Audits and may be responsible for site regulatory compliance and programs, and serve as divisional and Corporate Quality technical expert as required. Foster divisional teamwork within a continuous improvement environment

Essential Functions and Competencies

  • Capable of training regulatory and quality system requirements, concepts, auditing methods, and quality procedures within the Division and as required to support the Corporation. May manage ESD capability and programs, assuring compliance with and conformance to applicable ESD divisional requirements and commercial standards.

    May be able to provide day to day work direction for the ESD coordinator, and Production/Process Auditor team leader. Demonstrates effective customer interface skills. Demonstrates confidentiality Works with minimal supervision and guidance. Demonstrates effective interpersonal skills.

Qualifications / Education / Experience

  • Participates and contributes to quality departmental management meetings and goal accomplishment. Serves as technical support expert for external regulatory systems audits and customer audits/questions related to QSR and FDA requirements. Assists with the development and implementation of regulatory policy and procedures compliant with required standards within the Division and Corporation as required. Develops monitors and reports on key quality and performance indicators as related to Production/Process audit results. In conjunction with Manager Regulatory Systems, keeps updated on latest and future regulatory requirements, communicating to the division and corporation regulatory needs now and in the future. Champions selected continuous improvement initiatives. Recommends and selects new hires as well as recommends and performs disciplinary actions up to and including terminations.
    8+ years quality and regulatory experience; 3+ years in a leadership role in a multiple or large site.Attention Search Agencies:Please note that we are not accepting agency phone calls or referrals regarding position vacancies. Third parties should not submit resumes on this site or to Benchmark employees directly. If the decision is made to engage the services of a search agency, we only work with organizations on our preferred vendor list with whom we have a written agreement. If you would like to be considered for this list in the future please contact the local Human Resource office.
    4-year college technical degree or equivalent combination of education and experience.
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Manager Quality Systems

Stryker Corporation

Posted 2 weeks ago

VIEW JOBS 10/29/2018 12:00:00 AM 2019-01-27T00:00 Job Description Key areas of responsibility: (Detailed Description) * Lead top-priority quality-system related outputs of Global strategic planning into program or project proposals that may be implemented by one or more Global Process Owners and form them into short and long-term deliverables. * Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, EU MDR, and individual country requirements). * Ensure optimum state of QMS for current and future business needs. * Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process. * Drive development and/or modification of Stryker's QMS. * Oversee and/or manage Management Review and Quality Planning Review and related forums. * Assess and quantify requirements for QMS requirements to optimize structure. * Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of the QMS. * Liaise with global and corporate partners to provide best-in-class global solutions and input into processes. * Ensure development and delivery of training for QMS areas of expertise. * Responsible for the development, maintenance, and improvement of policies and procedures. * Liaise with notified bodies to manage certification changes. * Ensure QMS reflects actual activities, business needs and supports Divisional, GQO, and Corporate requirements. * Manage QMS activities to support achievement of project milestones. * Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects. * Represent expertise during internal and external quality system audits. * Strong knowledge of system integration. * Ensures future needs are identified and planned * Negotiates the best path forward based on available time, resources and the voice of the customer * Explores creative options within Stryker and external to Stryker as well * Builds strong relationships with local QMS leaders in order to identify improvement opportunities for the Global QMS as it is implemented at a local level, then takes the initiative to develop and propose an improvement approach * Viewed as a global resource for QMS expertise and strategy * Takes initiative and responsibility to plan, coordinate and complete complex projects * Prepares and conducts training on Global QMS contents and structure to new acquisitions * Leads the implementation of overarching Global Quality Management System programs or projects as a result of: * Organizational change in Stryker entities or their relationships to one another * Enterprise Platform projects * Local or company-wide acquisitions that require an increase in the regulations/standards that the Global QMS covers * Serve as a Global Process Owner, for Global Quality System Processes (Future State QMS Mapping and Maturity Modeling) by: * Coordinates division and adjacent GPO input and represent collective needs. * Owns global documents and training materials. * Updates Global Governance, RA/QA Leadership and PMO on direction and progress. * Ensures global initiatives are communicated and understood by stakeholders. * Serves as the voice of the process area for Stryker. * Travels to and leads hub and spoke meetings. * Leads meetings, surveys, information-gathering and global decisions for geographically dispersed teams. * Delivers against agreed project deadlines and reconciles implemented sites. * Communicates to leadership and stakeholders at a global level. * Leads global cultural change Education / work experience: * Bachelor's in Science or Engineering (or equivalent discipline) required * Master's degree (or equivalent) preferred * Minimum of 15 years' experience in regulated environments/regulatory agency interactions required * Experience serving in a leadership capacity for quality system activities required * Experience leading cross-site/cross-division projects required Knowledge / competencies: * Demonstrated ability to develop a strategic vision * Demonstrated ability to understand and navigate complex interpersonal and political issues. * Demonstrated versatility and a willingness to manage and lead a team through change and ambiguity. * Excellent interpersonal communication, collaborative teamwork, conflict management and negotiation skills. * Ability to present to, influence and build trusting relationships with executives. * Demonstrated ability to generate and explain complex opportunity analysis and value assessments accurately. * Demonstrated ability to mentor, train, and develop direct and indirect team members. * Expertise in quality system standards and regulations, including FDA 820, ISO 13485 and international standards, such as EU MDR, CMDCAS and Chinese GMPs * Demonstrated ability and expertise in leading quality assurance and systems as related to medical device design, production and distribution across multiple sites or entities * Strong ability to independently develop organizational relationships and trust * Excellent interpersonal and communication skills with senior management, including technical writing skills * Project management skills for projects spanning across different functional and international environments * Comfort and familiarity in presenting to leaders of business units * Ability to resolve conflict and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome * Builds consensus to achieve common goals * Able to generate clear policies and directives, as well as detailed procedures and instructions, that add value to the business as well as meet quality requirements * Can perform at a high level without constant supervision * Excellent time management and organizational skills Work From Home: No Travel Percentage: Up to 25% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Stryker Corporation Fremont CA

Manager, Regulatory And Quality Systems

Benchmark Electronics