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.

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.

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

QA/QC Engineer II

Key skills