Substation Physical Designer handling complex design tasks at Stanley Consultants, a global consulting engineering firm. Offering flexible work options and a commitment to innovation and client experience.
About the role
- Principal Quality Partner overseeing Design and Tech Transfer strategies for IVD assays at QuidelOrtho. Collaborating with cross-functional teams to drive compliance and quality initiatives.
Responsibilities
- Serve as the primary Quality partner to the Technology Transfer team, providing strategic guidance and oversight throughout assay design transfer and tech transfer activities.
- Lead development and execution of comprehensive design transfer and technology transfer quality strategies that ensure compliant, sustainable product realization.
- Collaborate with Design Quality, Quality Operations, R&D, and Manufacturing teams to ensure alignment on design transfer deliverables, risk management, and process capability expectations.
- Provide expert interpretation of applicable global regulatory and quality system requirements (e.g., ISO 13485, IVDR, FDA QSR) as they relate to design transfer, process transfer, verification/validation, and manufacturing readiness.
- Apply deep product and process knowledge to assess transfer risks, guide process understanding, and ensure adequate controls are defined and implemented during scale‑up.
- Support global audit and inspection activities as a subject matter expert and auditee for design transfer, tech transfer, and related quality system elements.
- Proactively identify quality gaps, systemic risks, and continuous improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions.
- Mentor engineers and contribute to development of organizational capability in design transfer strategy and regulatory compliance.
- Perform other work-related duties as assigned.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
- 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows.
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
- Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
- Expert-level knowledge of Design Transfer and Technology Transfer for IVD assays, including process readiness, scale‑up, and transfer of product requirements into manufacturing.
- Deep understanding of IVD regulatory and quality system requirements, such as ISO 13485, IVDR, FDA QSR, risk management (ISO 14971), and design control principles.
- Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows.
- Ability to interpret complex regulatory requirements and translate them into actionable design transfer and quality strategies.
- Demonstrated experience evaluating process capability, process controls, and design outputs to ensure manufacturability and compliance.
Benefits
- medical
- dental
- vision
- life
- disability insurance
- 401(k) plan
- employee assistance program
- Employee Stock Purchase Plan
- paid time off (including sick time)
- paid Holidays
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