Manufacturing quality engineering

Volpi Group Volpi is a leading manufacturer of optoelectronic modules that are at the core of In Vitro Diagnostics and Life Sciences instruments . Our products support global customers ranging from established instrument manufacturers to innovative start-ups in the medical technology sector.

To support our continued growth, we are looking for an experienced Senior Quality Engineer to join our Global Quality & Regulatory team at our office in Auburn, NY.

Key responsibilities: As a Quality Engineer , you will play a key role in ensuring product quality and regulatory compliance across development and manufacturing activities. You will work closely with R&D, Manufacturing Engineering, suppliers, and customers to maintain and continuously improve our quality systems and processes.

Provide quality engineering expertise to R&D and Manufacturing Engineering teams in compliance with ISO standards, FDA regulations, and internal policies

Support New Product Introduction (NPI), product transfers, and product lifecycle management activities

Manage and oversee non-conformances, CAPA, complaints, validations, change requests, and quality events

Contribute to the development and implementation of regulatory strategies for development projects

Analyze quality data and metrics using statistical approaches and drive continuous improvement initiatives

Support and participate in internal, external, supplier, and customer audits

Maintain and improve the Quality Management System (QMS) in alignment with global quality strategies

Lead or support risk management, safety, and surveillance activities

Collaborate with cross-functional teams to ensure compliance across the entire product lifecycle

Willingness to travel internationally (~10%)

Qualifications: Minimum of Bachelor degree in a Scientific, Technical, Business discipline

4+ years of experience in a manufacturing facility.

Experience in medical device or other highly regulated industrial environment.

Experience with QMS, validation and verification processes, failure investigations

Ability to synthesize ideas for effective problem solving

Ability to work independently and in an organized manner

Developed interpersonal, teamwork and communication skills

Developed organizational skills and ability to manage multiple tasks, projects, priorities

Proficiency in Microsoft Office applications

Understanding of ISO 9001 required, ISO 13485 preferred

Previous audit experience required (observer, SME)

Our Offer: Salary range: $65,000 – $85,000 USD (commensurate with experience)

401(k): Company match up to 8% dollar-for-dollar

Health coverage: Majority company-paid premium, with additional low-cost supplemental options

Dental & vision: Company paid

Development: Targeted training and long-term growth opportunities

Work culture: Independent, varied role in a collaborative international environment

Extras: Flat hierarchies, short decision paths, employee events, and a motivated, supportive team

Important notice:

We do not accept unsolicited CVs from recruitment agencies.

Any CVs sent without a prior written agreement will be considered unsolicited, and we reserve the right to process them without incurring any agency fees.

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