Manage the Quality Management System and contribute to the project teams by reviewing prints, risk assessments, and quality planning. This includes communication with Engineering on inspection methods, materials, and suppliers.
- Reviews proposed changes to determine if regulatory filings are required.
- Approves Regulatory documents with respect to product quality.
- Serve as a team member to provide quality assurance and risk management expertise to product development teams.
- Maintain company compliance of FDA Quality System Regulations, ISO 13485 standard, the Medical Device Directive, and the Canadian Medical Device Regulations.
- Conduct failure and hazard analysis for development projects.
- Conduct internal quality and external supplier audits.
- Performs receiving inspection & product release activities.
- Assists in the company’s complaint and failure investigation process.
- Manage test protocol & report development for validations.
- All other duties as assigned.
SKILL AND EDUCATION REQUIREMENTS:
- 7-10 years’ experience of Quality Engineering / Management in a medical device / biotech company / other regulated industry.
- Bachelors of Science in Engineering or related technical field preferred, OR equivalent in experience and training.
- In-depth knowledge of a quality system and ISO standards.
- Knowledge of basic statistical and engineering principals is essential.
Interested parties should submit their resume via the form below.
You may also submit via mail to:
ATTN: Chris Cook
210 N. Buffalo St.
Warsaw, IN 46580