Quality Engineer supporting and improving operational quality within cross - border transportation and supply chain. Ensuring compliance with regulatory requirements and driving process standardization.
About the role
- Staff Design Quality Engineer at QuidelOrtho responsible for Quality systems across the product lifecycle. Expertise in regulatory requirements for IVD products ensuring compliance and continuous improvement.
Responsibilities
- Execute Quality engineering activities that support business and compliance needs, ensuring timely delivery of high‑quality outputs.
- Apply technical, regulatory, and Quality systems knowledge to ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
- Support harmonization and standardization of Quality processes, procedures, and tools across sites and functions to improve consistency and efficiency.
- Partner with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
- Identify and support continuous improvement opportunities, including simplification, process excellence, and digital enablement within the Quality Management System (QMS).
- Maintain a state of inspection readiness and participate in regulatory agency, notified body, and internal audit activities as a Quality representative.
- Utilize Quality metrics and data analytics to identify risks, support root cause analysis, and implement sustainable corrective and preventive actions.
- Mentor and provide technical guidance to peers and junior team members to strengthen organizational capability.
- Communicate Quality‑related risks, progress, and recommendations to project teams and cross‑functional stakeholders.
- Perform other work-related duties as assigned.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
- 7+ 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.
- 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.
- Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline (preferred).
- Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools (preferred).
- Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise (preferred).
- Experience supporting or leading Health Authority or Notified Body inspections (preferred).
Benefits
- medical, dental, vision, life, and disability insurance
- 401(k) plan
- employee assistance program
- Employee Stock Purchase Plan
- paid time off (including sick time)
- paid Holidays
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