- Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures
- Provide expertise is risk management and analysis techniques when facilitating completion of risk management plans/reports, hazard/harm analysis, and FMEAs within a cross-functional team
- Assists teams in developing robust user, product, and labeling requirements
- Ensure that required standards for products are identified and documented in the product requirements (PR) specification and assist teams in demonstrating conformance to applicable standards
- Ensure the use of statistically valid sampling techniques
- Author the Quality, Risk and Usability sections of Design Control Quality Plans (DCQP)
- Provide expertise in evaluating design and process changes for impact to existing verification and validation
- Represent Quality initiatives and compliance when participating and Design and Phase reviews
- Participates in 3rd party audits
- Supports Quality System Software projects
Required Knowledge, Skills and Abilities:
- Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
- Knowledge of ISO 13485 and FDA requirements and how they relate to design control, risk management, and other quality practices.
- Good analytical and problem solving skills.
- High level of attention to detail and accuracy.
Minimum Requirements: minimum requirements for the position.
- Bachelor's Degree in Engineering or Science, or equivalent work experience.
- A minimum of two years related manufacturing experience in a QMS environment.
- Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.
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