Key position in medical device software company. BSCS or BSEE required. US citizen or permanent resident. Software experience required. Knowledge of regulatory requirements related to FDA/medical device software is highly desirable. Software testing and embedded experience are pluses. CriTech Research is a leading medical device software company based in Saline, MI. We’ve been in business since 1994. We offer stimulating work in an excellent environment. Competitive compensation and benefits.
Responsibilities include:
· Maintain the corporate quality system (QS) documents, quality records, and QS internal website.
· Audit company activities for compliance to the QS.
· Conduct management reviews as directed by company President.
· Serve as primary contact for ISO audits and audits by customers.
· Oversee the corrective & preventive action (CA/PA) and Process Improvement Recommendation (PIR) databases.
· Serve as the QA Engineer for engineering projects.
Please note this position is in Saline, MI, a suburb of Ann Arbor, and is not a remote position. CriTech does not intend to provide relocation expenses.
Job Type: Full-time
Pay: From $85,000.00 per year
Benefits:
- 401(k) matching
- Health insurance
- Health savings account
- Life insurance
- Paid time off
Schedule:
Experience:
- ISO 9001: 1 year (Preferred)
Work Location: In person