Quality Engineer II

Freudenberg · Beverly, MA

The role in 30 seconds

An engineer-level quality role at Freudenberg (industrial) in Beverly, MA.

Read from the posting. The full description is below.

It asks for 3+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Pulled from the posting text. If it's not listed here, the posting didn't say.

Five moves over a week or two. The first one takes ten minutes.

1
Pick 2–3 people on the Quality team at Freudenberg
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

◆Apply quality standards to support the development, qualification and manufacturing of products to meet internal and external requirements.
◆Apply statistical tools to analyze data, drive acceptance decisions, improve process capability, and support continuous improvement and lean initiatives.
◆Lead Measurement System Analysis (MSA) and supporting product acceptance activities.
◆Support and collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to ensure all change related items are adequately assessed, documented and tested as required.
◆Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, ensure sound start-up of new processes and equipment and development of all quality related documentation.
◆Lead resolution of nonconformances, complaints, CAPAs, etc. to resolve quality issues for assigned projects.
◆Support supplier quality activities such as supplier selection, qualification, documentation, audits, etc. (QA in FM COS would not oversee, may participate).
◆Participate in and occasionally lead internal and external audit.
◆Provide guidance to technicians ensuring effective daily support for ongoing tasks.
◆Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.

✓Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
✓3+ years’ experience in Medical Device or a related regulated industry.
✓Strong verbal and written communication skills with the ability to effectively collaborate across cross-functional teams, including Quality, Engineering, Operations, and customers, to drive problem-solving and continuous improvement initiatives.
✓Understanding of statistical methods, process control, internal/external audits, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&T and fixturing.
✓Demonstrated experience in metrology and quality inspection within a manufacturing environment, including Micro-Vu and Keyence measurement systems.
✓Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
✓Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.
✓Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory

(i.e., 21 CFR 820 in the United States).

Freudenberg Medical LLC

Show full description ↓

Working at Freudenberg: We will wow your world!