Are you looking for an exciting new career opportunity?
Invenia Group has partnered with a fast-growing biopharmaceutical company seeking a highly motivated and experienced Device Quality Assurance professional to provide technical leadership and Quality oversight to device and combination product development projects, as well as commercial manufacturing activities.
This position plays an integral role in working with cross-functional team members and contract organisations to define and execute device strategies for all assigned programs. This individual will also be responsible for ensuring all Design Control and cGMP elements are satisfied and fully compliant with applicable regulations.
Role Responsibilities:
- Serve as the primary quality lead for all combination product activities with a strong emphasis on design control and risk management.
- Oversee combination product development projects to ensure compliance with applicable quality regulations.
- Manage and maintain supplier quality oversight, including audits, performance monitoring, and quality agreements.
- Lead and support sustaining engineering efforts to ensure continued compliance and improvement of marketed combination products.
- Review and approve design control documentation.
- Lead change management assessment and implementation for combination products.
- Review Complaint Investigations and trending and support escalation processes, including CAPAs as needed.
- Represent the company in internal and external quality audits and inspections.
- Maintain and improve quality systems in alignment with the combination product requirements under 21 CFR Part 4.
- Provide executive-level guidance on quality strategy, risk management, and regulatory expectations.
- Develop and implement quality processes and documentation that are fit-for-purpose and scalable.
- Work cross-functionally with Device Engineering, Regulatory, Operations, and CMOs to ensure product quality and compliance.
- May provide guidance and work direction to other team members.
What We Are Looking For:
- Bachelor’s degree in engineering or related field (Biomedical/Mechanical Engineering preferred).
- ASQ Certified Quality Engineering and/or Certified Six Sigma Blackbelt (CQE or CSSBB) preferred.
- 12+ years of experience in and demonstrated knowledge of quality assurance for the development of medical devices and/or drug-device combination products, such as autoinjectors, prefilled syringes, or on-body injectors (Medical Device /Pharmaceutical industry).
- In-depth knowledge of industry regulations: QSR/cGMP and ISO/ICH standards (21CFR820, ISO 13485, ISO 14971, TIR 105, ICH Q9, ISO 10993, ISO 11608, IEC 62366, 21CFR Part 4).
- Thorough understanding of Statistical Methods for Quality Assurance, including Measurement System Analysis (MSA), normality tests, capability analysis, tolerance intervals, and Gage R&R.
- Knowledge and a comprehensive understanding of medical device manufacturing processes.
- Experience with root cause investigations and CAPA.
- Strong experience in supplier management, including quality agreement generation and maintenance.
- Clear and professional communication skills, both written and verbal, with the ability to convey complex information to varied audiences.
- Ability to manage workloads and aggressive timelines, prioritise and work under pressure.
Sound interesting? Apply today to find out more.
