Is This The Role For You?
We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.
If you're ready for a career that allows you to grow and develop into the professional you want to be - today and in the future.CryoLife is the place for you.
This position utilizes Quality Engineering and Quality Assurance techniques and expertise to provide management and functional support for new product development and product line support. This position also ensures that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products for US and Europe.
Defining, implementing and improving assigned Quality program and governance.
Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
Interprets government regulations, agency guidelines, and internal policies to assure compliance.
Partners with Subject Matter Experts to drive development of clear objectives for education packages that improve competency.
Program management responsibilities may include planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams.
Ensures results meet requirements regarding technical quality, reliability, schedule, and cost.
Consults on development of quality improvements and recommends alternatives. Guides the architecture, governance, and measurement of assigned programs. Manages the development and implementation of system level improvement plans across a variety of areas to increase efficiency, reduce cost and streamline operations.
Demonstrates excellent technical writing when authoring assigned Product Risk Assessment, Health Hazard Analyses, Post-Market Surveillance Reports. Facilitates Design FMEA and Risk Management File updates on assigned product lines.
Create, review and approve Protocols, Process and Product Validations.
Create, review and approve documents required for the Design History File.
Leads or owns in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCMRs, CAPAs, deviations, manufacturing process problems etc.) to assess impact on device quality and product availability.
Oversees and manages the operational aspects of ongoing projects. Monitors the project from initiation through delivery. Reviews status of projects and budgets; manages schedules and prepares status reports. Assesses project issues and develops resolutions to meet productivity, quality goals and objectives.
Partners with multiple manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Helps create qualification strategies to implement complex changes.
Perform Internal or Supplier Quality System Audits, as assigned.
Develop Validation Master Plans and Validation Project Plans to ensure that all validation tasks required supporting operational areas and corporate projects are identified and completed within established time frames.
Bachelor's Degree in Engineering, Science, or Technical field with 5+ years of experience in quality, engineering, operations and/or program management or Advanced Degree in Engineering, Science or Technical field with 3+ years of experience in quality, engineering, operations and/or program management
Experience with cardiovascular implantable medical devices
Knowledge and experience in application of statistics and lean sigma principles
Knowledge of cardiac anatomy, physiology, and primary disease states
Working knowledge of 21 CFR Part 820 (Quality System Regulation), ISO 13485, EU Medical Device Directive and relevant international standards
Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, DFMEA)
Demonstrated ability to work in a matrix organization and positively influence strategy and outcomes
Ability to deliver on multiple projects simultaneously, and balance between long- and short-term priorities
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win, own the whole)
ASQ, CQE, CQA Certification preferred, but not required.
Must be legally authorized to work in the United States
Must be willing to submit to a pre-employment background check and drug screen
Must be at least 18 years of age
Who We Are.
CryoLife is one of the world's leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.
CryoLife is an Equal Opportunity/Affirmative Action employer.
CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.