Plant Quality Assurance Manager overseeing safety and quality assurance functions in manufacturing plant. Managing compliance and quality systems to meet standards and regulations.
About the role
- Quality Assurance Engineer ensuring compliance with medical device regulations in a leading provider of O&P. Overseeing QA/QC activities, managing CAPA, and product validations.
Responsibilities
- 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 to ensure that measuring and critical operational equipment is timely calibrated and validated.
Requirements
- Minimum: Bachelor’s degree in Biochemical, Chemical engineering
- Minimum of 2 years of related experience
- Preferred MS in 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
- Ability to work and interact with internal and external parties including internal customers, distributors, suppliers.
- Ability to work in multi-tasked environment with deadlines.
- Strong ability to work independently on multiple time sensitive projects.
- Strong written and oral communication skills.
- Knowledge of medical device development and commercialization
- Understanding of electronic assembly and component manufacturing processes.
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
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