Provide quality support for Our Clients product development and change control. The Principal Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with Our Clients quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, Medical Device Regulation (EU MDR) and other applicable regulations and standards). The Principal Quality Engineer will provide quality assurance support for product realisation/manufacturing teams. Reporting to the Sr. Manager Design Quality, this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilising appropriate processes to design the highest level of quality into products as they are developed.
Essential Duties & Responsibilities
- Effectively utilise quality tools and processes such as product and process controls, risk analysis/management tools, overall design controls, design verification, design validation, investigations, CAPA data, etc. to assure product quality.
- Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Completes and works on complex design quality engineering projects with peer input and guidance from design quality engineering management.
- Provides compliance guidance concerning development, application, planning and execution of design verification and validation and maintenance of quality standards as related to product development within the quality system.
- Active participant in developing and maintaining product risk management files in line with ISO 14971.
- Applies advanced statistical sample size calculations to work for quality determination on projects
- Work with cross-functional teams to coordinate product changes.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Provide quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.
- Ensure that potential product and process risks are evaluated, prioritised, and mitigated to continuously improve product quality.
- Utilise a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.
- Ensure compliance, alignment and consistency with Our Clients quality system.
- Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
- Work special projects as assigned
Knowledge & Skills
- Expert in quality compliance, audit, and investigation skills
- Conducts investigations of considerable complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results.
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
- Strong knowledge of medical device standards, including but not limited to:
- In depth experience with and knowledge of FDA, EU MDR, and other key medical device regulations
- Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables as applicable)
- Advanced analytic thinking skills that enable identification of issues after analysing available data and discerning different patterns that lead to advanced conclusions and solutions
- Proven ability to work closely with engineering and manufacturing team members
- Knowledge and expertise in the design and development and clinical application of Respiratory and Anaesthesia medical devices, preferred
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor's degree from an accredited college or university is required in Mechanical Engineering, Bio Engineering, Materials Science, Physics
- Minimum 10+ years experience in R&D or Quality is required.
- ASQ CQE certification required or the ability to obtain within one year.
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel 5% to 10% of the time