About this role
Role Overview
- Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 12345:2003, and CE mark during design, manufacturing, and product fulfillment process.
- Perform incoming inspections, final product release inspections, and preliminary product failure investigation/testing as a part of CAPA process.
- Act as complaint management coordinator to receive and process all complaints related to ININC products.
- Manage document control activities according to the FDA and international regulations.
- Manage quality records including device history records, QA records, test reports, manufacturing records, and equipment records.
- Maintain and monitor product traceability data from receiving through the final destination.
- Perform validation activities including IQ, OQ, and PQ processes according to 21 CFR 820 and 21 CFR Part 11.
- Manage calibration programs and track equipment maintenance.
Requirements
- Minimum: Bachelor’s degree in electrical or mechanical engineering
- Minimum of 2 years of related experience
- Preferred MS in electrical or mechanical engineering is preferred.
- 3 years of experience in medical device industry, of which 2 years should be quality and regulatory affairs.
- Experience in manufacturing of medical device with electronic components is preferred.
- Broad understanding of 21 CFR 820, 21 CFR Part 11, ISO 13485:2003, and international regulatory requirements.
- Managing and leading CAPA program to be compliant to a defined quality system.
- Experience scheduling, managing internal audits and developing SOPs and Work Instructions.
- Experience as main company representative to be audited to FDA or ISO standards.
Benefits
- 8 Paid National Holidays & 4 additional Floating Holidays
- PTO that includes Vacation and Sick time
- Medical, Dental, and Vision Benefits
- 401k Savings and Retirement Plan
- Paid Parental Bonding Leave for New Parents
- Flexible Work Schedules and Part-time Opportunities
- Generous Employee Referral Bonus Program
- Mentorship Programs
- Mentor and Mentee
- Student Loan Repayment Assistance by Location
- Relocation Assistance
- Regional & National traveling CPO/CO/CP opportunities
- Volunteering for Local and National events such as Hanger’s BAKA Bootcamp and EmpowerFest