QA/QC Engineer II

Hanger, Inc.•Phoenix, AZ

About The Position

The Quality Assurance Engineer has the responsibilities to coordinate and perform quality assurance and product development activities according to medical device regulations of 21 CFR 820 and/or ISO 13485:2016, Medical Device Directive (MDD), ISO 13485, and ISO 14971. QA Engineer will be responsible for managing incoming inspection and product release activities. This includes ensuring incoming and final release products meet specifications and QA requirements. The duties will also include document control management, management of CAPA activities, product review investigations. QA Engineer will work with Product Development to ensure that design control process is followed for new and existing product lines.

Requirements

Bachelor’s degree in Biochemical, Chemical engineering
Minimum of 2 years of related experience
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.
Act with integrity in all ways and at all times, remaining honest, transparent, and respectful in all relationships.
Keep the patient at the center of everything that you do, building lifelong trust.
Foster open collaboration and constructive dialogue with everyone around you.
Continuously innovate new solutions, influencing and responding to change.
Focus on superior outcomes, and calibrate work processes for outstanding results.

Nice To Haves

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

Responsibilities

Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 13485:2016, 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. This includes ensuring that all complaints are processed in a uniform and timely manner according to 21 CFR 820, MDD, and ISO 13485:2016 regulations.
Manage document control activities according to the FDA and international regulations. This includes ensuring that all document changes are processed and approved according to the standard operating procedures.
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.

Benefits

Competitive Compensation Packages
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