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.

Contact

Johan Nuguse
Recruiter
Volpi AG
Phone: +41 44 732 43 83