Quality Engineer

Straumann • Andover, MA

38d

About The Position

The Quality Engineer strengthens product and process robustness across manufacturing by applying structured quality engineering principles, statistical analysis, and risk-based decision-making in a regulated medical device environment (ISO 13485, FDA QSMR, GMP).
This role partners closely with Manufacturing, QC, Engineering, Supplier Quality, and Operations to ensure product conformity, improve process capability, reduce scrap, and reinforce preventive controls. The Quality Engineer supports technology transfers, validation activities, internal audits, and supplier quality oversight while driving data-based continuous improvement.
The position provides technical leadership in quality engineering disciplines and ensures compliance, sustainability, and operational excellence across implant and prosthetic value streams.

Requirements

• Bachelor’s degree in Engineering or related technical field.
• Minimum 5 years of engineering experience in a regulated manufacturing environment (medical device preferred).
• May sit for extended periods of time.
• Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence.
• Spend significant time reading both on paper and on a computer.
• General office and manufacturing environment with moderate to high noise levels depending on task location.

Nice To Haves

• Six Sigma Green Belt or higher certification.
• Strong knowledge of statistical analysis, sampling methods, validation, MSA/GR&R, PFMEA, and structured problem-solving methodologies.
• Working knowledge of GMP, ISO 13485, FDA QSMR, and quality system requirements.
• Experience supporting internal or external audits.
• Demonstrated ability to work independently in a dynamic manufacturing environment.
• Strong analytical, organizational, and communication skills.
• Experience with supplier quality, PPAP, supplier audits, and SCAR management.
• Hands-on experience with CNC machining, metrology systems (CMM, optical inspection), or mechanical inspection.
• SAP and PLM experience.
• Experience training or mentoring employees at multiple organizational levels.

Responsibilities

• Develop and maintain robust quality plans including control strategies, sampling methods, inspection criteria, and metrology approaches.
• Conduct process capability studies, statistical analysis, PFMEA, risk assessments, and measurement system evaluations (MSA/GR&R) to reduce variation and improve process stability.
• Analyze scrap trends, NCR data, and yield performance to identify systemic improvement opportunities.
• Recommend and implement engineering solutions in compliance with ISO 13485, FDA QSMR, and internal quality system requirements.
• Develop and revise SOPs, work instructions, ECOs, control plans, and related documentation to ensure clarity and compliance.
• Support technology transfers and product introductions by defining quality requirements and inspection strategies.
• Execute and support IQ/OQ/PQ activities in alignment with the Validation Master Plan.
• Prepare and review validation documentation including protocols, reports, PFMEAs, and risk assessments.
• Conduct revalidation assessments to maintain long-term process compliance and risk mitigation.
• Provide structured troubleshooting support to machining, finishing, cleaning, packaging, and inspection processes.
• Lead or facilitate root cause investigations using structured methodologies (5 Why, Fishbone, 8D, DMAIC).
• Ensure corrective and preventive actions are timely, effective, and verified for sustainability.
• Collaborate with Manufacturing Engineering and Production teams to improve process flow and defect prevention.
• Plan, conduct, and document internal audits to ensure regulatory and corporate audit readiness.
• Serve as subject matter expert in manufacturing process audits, SPC, validation, and document control.
• Support audit responses, corrective action plans, and effectiveness verification within defined timelines.
• Ensure inspection plans, sampling strategies, and test methods remain aligned with regulatory expectations.
• Partner with Supplier Quality to qualify and monitor suppliers of machined components, coatings, raw materials, and surface treatments.
• Review supplier documentation including PPAPs, FAI reports, material certifications, and capability studies.
• Support supplier audits and corrective action processes (SCARs) as required.
• Apply Lean and Six Sigma tools to reduce variation, strengthen process control, and improve reliability.
• Support scrap reduction initiatives and process optimization projects across value streams.
• Monitor KPIs related to yield, defect rates, nonconformances, and process capability.
• Collaborate with SAP/PLM, Document Control, and cross-functional stakeholders to ensure data accuracy and traceability.
• Provide training and mentoring on quality tools and engineering best practices.

Benefits

• Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level