Quality Engineer

AMETEK; Mansfield (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

AMETEK, Inc., via Paragon Medical, seeks a Quality Engineer in Mansfield, MA. Under general direction you will create and maintain Quality Assurance functions, procedures and practices to identify, document, track, and resolve quality issues, supporting both engineering and manufacturing and reporting to the Quality Manager.

You will lead QA inspection plans, participate in ISO and FDA QMSR compliance, manage NCRs, CAPA and root‑cause analyses, and collaborate with customers, suppliers and

Qualifications

• Bachelor’s degree in Quality or Engineering; 2+ years in quality engineering.
• Experience with ISO 9001:2015 or ISO 13485:2016.
• Experience in medical device manufacturing is desirable.
• Familiarity with FDA QMSR 21 CFR 820 desired.
• ASQ CQE desirable.

Responsibilities

• Create and revise QA inspection plans and documents to meet ISO/FDA/QMS.
• Lead continuous improvement of quality processes.
• Review NCRs and provide dispositions with engineering teams.
• Investigate quality issues with CAPA and root-cause analysis.
• Support documentation control and training.
• Interface with customers, suppliers, and regulatory bodies.
• Assist in AI-driven productivity improvements.

Skills

Quality engineering

Regulatory compliance

CAPA

Root cause analysis

AI tools

GMP

Statistical analysis

Education

Bachelor’s degree in Quality or Engineering

Tools

Minitab

MS Office

Micro Vu

Job description

We are searching for a Quality Engineer who under general direction will create and maintain Quality Assurance functions, procedures and practices within the company. You will ensure that quality issues and defects are appropriately identified, documented, tracked, and resolved. You will support both engineering and manufacturing activities at the Mansfield site and report to the Quality Manager.

Key Responsibilities

• Create, implement and revise Quality inspection plans, procedures and documents in support of engineering (NPD and NPI) and manufacturing to maintain compliance with ISO/FDA regulatory requirements and Quality Management System (QMS) improvement.
• Continuous improvement activities as they apply to Quality, such as, but not limited to, improved inspection methods, etc.
• Coordinate review and processing of project related NCRs issued for incoming, in-process and final inspections. Work with Product Development Team or Manufacturing Engineering in providing appropriate dispositions (UAI, Scrap, RTV, etc.) of NCRs.
• Perform investigations on quality related issues, including CAPA, Complaints, Root Cause Analysis, etc. as required.
• Review/approval of documentation via Pre-Production Release or ECO.
• Interface with customers, suppliers, Project Team and Client Regulatory to resolve quality matters, as required.
• Provide necessary technical support to other departments such as engineering, sustaining engineering, and manufacturing activities.
• Work with all departments in implementing and complying with Quality Systems and GMP requirements.
• Support to Document Control as required (ie: review of lot release records, etc.).
• Assist in training inspection and production employees as required.
• Execute tasks assigned by the Project Manager when assigned to a Project Team.
• Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.
• Other responsibilities as required.

Position Requirements

• Bachelor’s Degree (BA/BS) in Quality or Engineering discipline with at least 2 years of quality engineering required.
• Working knowledge of ISO 9001:2015 or ISO 13485:2016 required.
• Working knowledge of Microsoft office applications required.
• Experience in a medical device manufacturing environment is desired.
• Inspection methods using vision system, calipers, micrometers and other related tools desired.
• Knowledge and experience with FDA QMSR 21 CFR:820 desired.
• ASQ certification such as, but not limited to, Certified Quality Engineer (CQE) is desired.
• Knowledge of statistical programs such as Minitab desired.
• Working knowledge of Micro Vu vision system programming desired.
• Demonstrated ability and willingness to use AI tools to improve productivity, decision‑making, work quality, and to reduce costs.The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.

Physical Demands

• Sitting, standing, walking, grasping, climbing, stooping, kneeling, or crawling as required.
• Occasional lifting, carrying, pushing, and pulling up to 25 lbs.

Work Environment

• Office environment with low noise levels and manufacturing plant as needed.

Paragon Medical, a business of AMETEK, Inc, serves as a strategic partner in medical device manufacturing, offering an end-to-end supply chain solution from initial concept and product development, to verification and validation testing, to final production, assembly, and ongoing strategic demand planning.

Compensation

Employee Type: Salaried

Currency: USD

Salary Minimum: 70,000

Salary Maximum: 90,000

Incentive: No

Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.

AMETEK, Inc. is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales over $7.5 billion.

AMETEK is committed to making a safer, sustainable, and more productive world a reality. We use differentiated technology solutions to solve our customers’ most complex challenges. We employ 22,000 colleagues, in 35 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK is a component of the S&P 500. Visit https://www.ametek.com/careers for more information.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1 [phone].