Manufacturing Engineering Quality Assurance Manager

Sonova
Kitchener
Workplace: HybridFull timeUSD 76,000 - 95,000 annuallyFunction: QA, Test & Release EngineeringSkills: ["Communication","Presentation","Stakeholder management","Negotiation","Problem-solving","Organized","Reliability","Root cause analysis"]

Lead end-to-end QA and regulatory compliance across Manufacturing Engineering and Services, driving quality activities, documentation control, and audit readiness. Partner with engineering and operations on design transfer, process validation, FMEA, nonconforming product disposition, CAPA, and change control. Monitor and improve operational quality metrics, with a strong focus on MDSAP and MDR compliance. Oversee investigations, complaint-handling documentation, and evidence gathering for internal and external audits.

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FursaFursa
Sonova
Sonova
23 hours ago

Manufacturing Engineering Quality Assurance Manager

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Last checked: 2 hours agoStatus: Live

Job Summary

Lead end-to-end QA and regulatory compliance across Manufacturing Engineering and Services, driving quality activities, documentation control, and audit readiness. Partner with engineering and operations on design transfer, process validation, FMEA, nonconforming product disposition, CAPA, and change control. Monitor and improve operational quality metrics, with a strong focus on MDSAP and MDR compliance. Oversee investigations, complaint-handling documentation, and evidence gathering for internal and external audits.
Location: Kitchener
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Manager level

Key Responsibilities

  • •Maintain and monitor QA activities and document control to ensure compliance with internal procedures and regulations, including MDSAP and MDR.
  • •Align with standards and regulatory requirements (ISO 13485, ISO 9001, FDA, MDR 2017/745) and support audit preparation, responses, evidence collection, and CAPA closure.
  • •Collaborate with Manufacturing Engineering and Global Services on design transfer, process validation, FMEA, non-product software validation, and equipment qualification/verification.
  • •Oversee evaluation and disposition of nonconforming products and processes, coordinating resolution with Quality Assurance, Reliability, Manufacturing Engineering, and Operations.
  • •Coordinate CAPA, support root cause investigations, perform change control impact analysis, and assist with complaint handling documentation and resolution.
Travel: Low travel

Pay and Benefits

Salary: USD 76,000 - 95,000 annually
Perks:Wellness StipendPension

Key Requirements

  • •Graduate degree in engineering, science, quality, or a related technical field required (Bachelor’s considered an asset).
  • •4+ years of experience in a medical device manufacturing environment in a quality-related role.
  • •Knowledge of ISO 13485, ISO 9001, MDR 2017/745, 21 CFR 820, and MDSAP required.
  • •Experience with design transfer, process validation, nonconforming product, and CAPA processes preferred.
  • •Advanced MS Office skills; SAP R/3 or S/4, eQMS, ServiceNow, and Planisware experience preferred.
Experience:Medical device manufacturing
Skills:CommunicationPresentationStakeholder managementNegotiationProblem-solvingOrganizedReliabilityRoot cause analysis
Tech Stack:MS OfficeSAP R/3SAP S/4EQMSServiceNowPlaniswareFMEACAPA

Company Brief

Sonova
Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Stäfa, Switzerland
Founded: 1947
Website