What are the responsibilities and job description for the Quality Engineer position at Global Technical Talent and Careers?
Primary Job Title:
Quality Engineer
Quality Engineer
Alternate/Related Job Titles:
Manufacturing Quality Engineer
Medical Device Quality Engineer
Quality Assurance Engineer
Supplier & Manufacturing Quality Engineer
Regulatory Quality Engineer
Manufacturing Quality Engineer
Medical Device Quality Engineer
Quality Assurance Engineer
Supplier & Manufacturing Quality Engineer
Regulatory Quality Engineer
Location:
Marlborough, MA
Marlborough, MA
Onsite Flexibility:
Onsite
Onsite
Contract Details (Contract roles only):
- Position Type: Contract
- Contract Duration: 6 Months
- Start: As Soon As Possible
- Pay Rate: $44 - $46/hr
Job Summary:
The Quality Engineer 2 ensures medical device capital equipment manufacturing operations meet the highest quality standards by supporting manufacturing quality control and regulatory compliance. This role collaborates across teams to drive continuous improvement, maintain robust process controls, and deliver innovative solutions that support product quality, safety, and reliability.
Through integrity, operational excellence, and a customer-focused mindset, the Quality Engineer 2 contributes to organizational success by supporting manufacturing operations and ensuring compliance with regulatory and quality system requirements.
Key Responsibilities:
- Support daily manufacturing quality operations, including nonconforming event (NCE) investigations, rework approvals, and equipment record reviews.
- Lead NCE investigations to evaluate the impact of nonconforming materials on product quality and compliance.
- Determine containment actions, perform root cause investigations, assess risks, and collaborate with cross-functional stakeholders.
- Drive timely disposition, release activities, and resolution efforts aligned with regulatory and quality system requirements.
- Monitor NCE data to identify trends and areas for improvement through data-driven decision making.
- Initiate and drive corrective actions to address unfavorable trends and maintain product quality and compliance.
- Assess equipment controls including validation, calibration, and preventative maintenance.
- Conduct out-of-tolerance investigations and approve equipment records to ensure device manufacturing validity.
- Support additional quality engineering activities including process validation, documentation review, and engineering collaboration.
Required Experience:
- Bachelor’s Degree in Engineering or related discipline, or equivalent combination of education and experience.
- 2–4 years of experience as a Quality Professional in the Medical Device industry or related regulated industry.
- Experience supporting manufacturing quality operations and compliance activities.
- Experience performing root cause investigations and corrective actions.
Nice-to-Have Experience:
- Experience with Class II or Class III medical devices and IVD device capital equipment.
- Experience supporting New Product Introduction (NPI) and design transfer activities.
- Experience with test method validation and process validation (IQ, OQ, PQ).
Required Skills:
- Nonconforming event (NCE) investigation and root cause analysis
- Quality systems and regulatory compliance
- Manufacturing process quality support
Preferred Skills:
- ISO 13485 and FDA regulatory compliance
- Risk management and ISO 14971
- CAPA management and quality investigations
- Statistical analysis tools and Six Sigma methodologies
- Equipment validation and calibration processes
Additional Skills:
- Process FMEA development
- Corrective and Preventive Actions (CAPA)
- Test Method Validation (TMV)
- Process Validation (IQ, OQ, PQ)
- EU MDR / IVDR compliance
- cGMP requirements
- Statistical Process Control (SPC)
- Design of Experiments (DOE)
- Technical documentation and procedure review
- Quality Management Systems (QMS)
- Data analysis and enterprise systems usage
- Good Documentation Practices (GDP)
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About the Client:
Innovative medical technology company empowering healthier lives. Focuses on women's health and well-being. Offers products to detect, diagnose, and treat illnesses earlier. Driven by talented employees and a commitment to science-based solutions.
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number:
26-02263
26-02263
Hashtags:
#gttic #gttjobs
#gttic #gttjobs
Salary : $44 - $46