Quality Assurance Engineer

Datwyler; Town of Middletown (NY); On-site; USD 85,000 - 120,000; Full time

Job summary

Datwyler, a Swiss high‑tech company, seeks a Quality Engineer to ensure products, processes and quality systems meet internal standards and regulatory obligations. This role supports manufacturing and new product introduction through risk management, process validation, and CAPA, contributing to patient safety and product excellence.

Expect 2–5+ years in a regulated manufacturing environment, with strong ISO 13485 and FDA knowledge; molding/precision manufacturing experience is a plus.

Qualifications

• Bachelor’s degree in Engineering, Quality, Science, or related field.
• 2–5+ years of quality engineering in a regulated manufacturing environment (medical device, pharma, healthcare packaging).
• Experience with molding or precision manufacturing preferred.

Responsibilities

• Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR and other regs.
• Support audits and lead follow-up activities; maintain documentation.
• Maintain and improve quality procedures, work instructions, and records.
• Provide QA support for manufacturing processes (molding, assembly, inspection, packaging).
• Lead CAPA, PFMEA, Control Plans and risk management activities.
• Support NPI quality planning and supplier qualification; investigate customer issues.

Skills

Quality engineering

Regulated manufacturing

ISO 13485

SPC

Education

Bachelor’s degree in Engineering/Quality/Science

Tools

MS Office

eQMS systems

Statistical tools

Job description

Select how often (in days) to receive an alert:

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Position Summary

The Quality Engineer at Datwyler is responsible for ensuring that products, processes, and quality systems comply with internal standards, customer requirements, and applicable regulatory requirements. This role supports manufacturing and new product introduction through risk management, process validation, continuous improvement, and root cause analysis, contributing to Datwyler’s commitment to patient safety and product excellence.

Essential Functions

Quality Systems & Compliance

• Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulatory and customer requirements.
• Support internal, external, customer, and regulatory audits; prepare documentation and lead follow-up activities.
• Maintain and improve quality procedures, work instructions, and records.

Manufacturing & Process Support

• Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.
• Oversight process validations (IQ, OQ, PQ) and maintain validation documentation.
• Participate in PFMEA, Control Plans, and risk management activities.
• Support containment, investigation, and resolution of nonconformities.
• Oversight and support root cause investigations using tools such as 8D, Fishbone, and 5-Why.
• Implement corrective and preventive actions (CAPA) and verify effectiveness.
• Drive continuous improvement initiatives using Lean and Six Sigma methodologies.

New Product Introduction (NPI)

• Support quality planning and risk assessments for new products and transfers.
• Review customer specifications, drawings, and validation requirements.
• Ensure quality deliverables are completed on time for project milestones.
• Support supplier qualification, audits, and performance monitoring.
• Investigate customer complaints and ensure timely, compliant responses.
• Collaborate with customers to resolve quality issues and improve satisfaction.

Qualifications

Education

• Bachelor’s degree in Engineering, Quality, Science, or a related discipline.

Experience

• 2-5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging.
• Experience with molding or precision manufacturing processes preferred.

Technical Skills

• Strong knowledge of:
• ISO 13485
• FDA 21 CFR 820
• Process validation
• Experience with statistical tools and SPC.
• Proficiency in MS Office; experience with eQMS systems is a plus.

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.