Quality Engineer in Stoughton

Energy Jobline ZR; Stoughton (MA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work schedule

401(k) retirement plan

Medical/Dental/Vision coverage

Paid time off

Job summary

Amphenol Alden is seeking a Quality Engineer at our Stoughton, MA facility to maintain product quality, support customer requirements, and drive continuous improvement in manufacturing processes. You will collaborate with engineering to develop inspection plans, address nonconformances and CAPA, perform FAI and capability studies, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.

We offer a hybrid work schedule, a competitive benefits package including medical, dental, vision,

Qualifications

• At least 3 years of related experience in a manufacturing environment in a Quality Engineer role.
• Knowledge of ISO 13485:2016 and FDA medical device quality system requirements under 21 CFR Part 820.
• Familiarity with PFMEA, Process Control Plans, Process Maps and other quality/engineering processes.
• Knowledge of process validation including IQ, OQ, and PQ.
• Proficiency with Microsoft Office applications; Minitab is a plus.
• A four-year college degree, preferably in Engineering or related field, or equivalent hands-on experience.
• Strong organizational, communication, problem-solving, and analytical skills.
• Ability to travel to AAP facilities, suppliers, and customer locations, including international travel.

Responsibilities

• Collaborate with Engineering to develop customer inspection plans and documentation packages.
• Address nonconformances, quality alerts, and CAPA with customers.
• Perform First Article Inspections (FAI), process capability (Cpk) studies, and GR&R studies.
• Support quality planning, process controls, and validation activities.
• Help ensure compliance with medical device regulations and customer requirements.

Skills

Problem-solving

Analytical skills

Communication skills

Organizational skills

Education

Four-year college degree in Engineering or related field

Tools

Minitab

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job DescriptionJob Description

Join Amphenol Alden and Make a Difference in Patient Care Worldwide!

Are you a Quality Engineer who enjoys solving problems, improving processes, and ensuring products meet the highest standards of quality? Join Amphenol Alden Products (AAP) and help support the medical technologies that make a difference in patient care around the world.

With roots as a family business more than 90 years ago, Amphenol Alden combines a proud history and entrepreneurial spirit with the resources of a global corporation. As our business continues to grow, we're looking for talented professionals who want to contribute, collaborate, and grow with us.

We're excited to welcome a Quality Engineer to our team at our new Stoughton, Massachusetts facility.

What You'll Do

As a Quality Engineer, you'll play an important role in maintaining product quality, supporting customer requirements, and driving continuous improvement in our manufacturing processes.

Key responsibilities include:

• Collaborate with Engineering to develop customer inspection plans and supporting documentation packages.
• Work directly with customers to address nonconformances, quality alerts, and Corrective and Preventive Actions (CAPA).
• Perform First Article Inspections (FAI), process capability (Cpk) studies, and Gage Repeatability and Reproducibility (GR&R) studies.
• Support the development and implementation of quality planning, process controls, and validation activities.
• Help ensure compliance with applicable medical device regulations, quality standards, and customer requirements.

What We’re Looking For

• At least 3 years of related experience in a manufacturing environment, including experience in a Quality Engineer role.
• Knowledge of ISO 13485:2016 and FDA medical device quality system requirements under 21 CFR Part 820.
• Familiarity with PFMEA, Process Control Plans, Process Maps, and other quality and engineering processes.
• Knowledge of process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint; experience with Minitab is a plus.
• A four-year college degree, preferably in Engineering or a related field, or equivalent hands‑on experience.
• Strong organizational, communication, problem‑solving, and analytical skills.
• Ability to travel as needed to AAP facilities, suppliers, and customer locations, including international travel.

Additional Qualifications We Value

• Lead Auditor training in ISO 13485:2016 or ISO 9001:2015.
• Familiarity with REACH, RoHS, and conflict minerals requirements.
• A self‑motivated, organized approach with the ability to work collaboratively across teams and with customers.

What We Offer

At Amphenol Alden, we recognize that our employees are essential to our continued success. We offer a competitive compensation and benefits package designed to support your financial well‑being, health, and work/life balance.

• Competitive salary and bonus opportunity
• Hybrid work schedule
• Excellent 401(k) retirement savings plan for your future
• Comprehensive benefits, including medical, dental, vision, life insurance, and short- and long-term
• Paid time off (PTO), Health Savings Account (HSA), and Flexible Spending Account (FSA)
• Employee discounts and company activities
• The opportunity to contribute to products that support patient care worldwide

Ready to make a difference?

Join Amphenol Alden and become part of a growing team where quality matters and your work helps support patient care around the world.

Amphenol Alden Products is an Equal Opportunity Employer

Applicants must be legally authorized to work in the United States without current or future employer sponsorship.