Quality Engineer

Volpi Manufacturing Co. Inc.; City of Auburn (NY); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Salary range

401(k)

Health coverage

Dental & vision

Training & growth

Work culture

Job summary

Volpi Group in Auburn, NY is seeking an experienced Senior Quality Engineer to join the Global Quality & Regulatory team. You will ensure product quality and regulatory compliance across development and manufacturing, collaborating with R&D, Manufacturing Engineering, suppliers, and customers.

The role requires 4+ years in a regulated environment, expertise in QMS and ISO 9001/13485, and occasional international travel (~10%).

Qualifications

• Bachelor degree in a Scientific, Technical, or Business discipline.
• 4+ years in a manufacturing facility.
• Experience in medical device or other highly regulated environments.
• Experience with QMS, validation and verification, and CAPA processes.
• Audit experience (internal, external, supplier, or customer).

Responsibilities

• 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.
• Manage non-conformances, CAPA, complaints, validations, change requests, and quality events.
• Contribute to regulatory strategies for development projects.
• Analyze quality data using statistical approaches and drive continuous improvement initiatives.
• Support audits (internal, external, supplier, and customer).
• 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%).

Skills

Quality engineering

ISO standards

Regulatory knowledge

CAPA

QMS

Audits

Data analysis

Cross-functional collaboration

Education

Bachelor degree in Science/Engineering/Business

Tools

Microsoft Office

Job description

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.