Ann Arbor, United States
over 1 year ago
- Support in ensuring process compliance for SW medical device development e.g. perform design and documentation reviews, support the project regarding process and regulatory compliance by working with them and providing required trainings.
- Support continuous process improvement of Quality Management System.
- Support process measurement initiatives, including scorecards and other metrics, which can also be used to drive process improvements.
- Support in analyzing defects, complaints, SW code changes and process changes.
- Supports in obtaining proper market approvals (such as 510(k), PMA(s), CE marking etc.).
- Support in audit preparations.
- The position requires interactions and cooperation in a multisite and multinational environment.
- For the candidate to be considered for this position they must have:
Working knowledge in relevant medical device standards and regulations such as FDA QSR, 93/42/EEC Medical Device Directive (MDD), ISO 13485, ISO 9001.
Working knowledge in development of medical device software. Excellent written and verbal communication and intercultural skills.
BS/BA Required, Advanced degree preferred. Candidate should be able to Analyze complex development, test and production related quality trend data to identify and solve problems
Devise sampling procedures and designs and develops systems for recording, evaluating, and reporting quality and reliability data.
Prepare reports of findings and carries out complicated implementation and training assignments.
Conduct document reviews and/or surveys to determine acceptability of quality controls.
Demonstrate and apply a broad knowledge of field of specialization through successful completion of moderately complex assignments.
Successfully apply complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization.
Demonstrate knowledge of organization's business practices and issues.
Typically 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above.
Advanced degree may be substituted for experience, where applicable.