Product Quality Engineer

Overview

Job Summary:

Working within the Quality & Regulatory Affairs department, the Product Quality Engineer plans, coordinates, and manages quality assurance and quality control activities associated with product development, product manufacturing and post-product release to ensure internal and external compliance.

The Product Quality Engineer is responsible for defining and developing DHF deliverables e.g. Quality Plans, Supplier Qualification Strategies/Quality Agreements, Manufacturing Quality Plan, and Design Verification protocols and reports. They also oversee, review and conduct Design and Development File Verification and Validation at the end of each design control phase.

The Product Quality Engineer provides quality control support for Adaptix outsourced manufacturing and owns product-relevant NCR and CAPA processes.

The Product Quality Engineer provides colleagues with clear, consistent, pragmatic and timely guidance as it relates to compliance exposure and provides innovative solutions to effectively resolve investigations and meet the needs of customers, regulatory bodies and wider strategic aims.

See above table for the reporting structure and refer to the Organisation Chart for more information about where this role sits within the Adaptix structure.

Main duties and responsibilities:

• Provide focused quality engineering leadership, guidance and training and assume responsibility for timely and effective coordination and/or execution of assigned project activities for Adaptix medical, veterinary and non-destructive testing systems.
• Work with colleagues to ensure that all applicable elements and product technical standards are effectively incorporated into new designs and into design changes (change assessments for up to Class IIb CE and Class II FDA medical devices).
• Provide input to design and manufacturing documentation (material specifications, drawings, inspection procedures, and manufacturing procedures) to ensure products can be adequately manufactured and tested.
• Support the R&D team with Verification and Validation activities, including internal and external testing.
• Contribute to design input requirements, applying learning from previously reported problems (non-conforming material reports, yield, rework) or external sources (customer complaints, competitive devices / similar products).
• Lead and support Risk Management activities for new and/or modified products and processes, ensuring risk assessment occurs in the appropriate project phase, authoring risk management plans and reports, and facilitating risk assessment activities.
• Review and approve or reject technical transfer plans and reports from a design transfer perspective.
• Represent the Quality team in supplier selection process and component specification reviews to ensure purchased and proposed items meet specifications.
• Develop and validate quality test methods.
• Support quality system development and implementation throughout the product life cycle.
• Identify opportunities for continuous improvement and work with colleagues to support and implement quality and engineering changes.
• Generate internal quality documentation (e.g. quality plans, SOPs, work instructions and inspection procedures).
• Own the non-conformance processes, including CAPAs related to product development / product quality.
• Support colleagues with internal audits and risk assessments, taking corrective actions where necessary.   
• Work collaboratively to implement Product Quality practices and procedures compliant with relevant standards including ISO 13485:2016, 21 CFR 820 (and transition to QMSR) and CE Marking/510k for medical devices.

Qualifications:

• Undergraduate degree in Science or Engineering, or equivalent experience.
• Recognised Quality Management System qualification (e.g. ISO implementation or internal auditor) or equivalent experience.

Skills:

• Solid knowledge across engineering, new product development and manufacturing disciplines, ideally in active electromedical devices incorporating software.
• Ability to provide quality engineering advice in a professional, credible manner.

• Ability to interpret product safety and other regulatory standards, including medical device cybersecurity.
• Excellent planning skills with the ability to manage concurrent projects and adapt to changing priorities. Maintains a high level of performance and remains calm when facing pressure and uncertainty.
• Effective communication of technical requirements both verbally and in writing.
• Ability to problem-solve, analyse data, spot trends, identify and document issues, with the confidence to suggest and implement agreed process improvements.
• Builds effective internal and external relationships, working effectively both independently and collaboratively.

Experience:

• Implementing Lean/Six Sigma principles, or equivalent manufacturing/business optimisation processes.
• Working in a Engineering / Quality role within highly regulated industries with process-driven environments.

• ISO / medical device-related standards, including software and cybersecurity.
• Experienced in using quality tools and statistical programs such as Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC).

Quality Management

Adaptix operates within the medical devices domain which is a regulated environment. All employees are expected to work to policies and procedures defined within the company’s quality management system and employee handbook and in adherence to relevant quality standards and codes of conduct.

All employees are expected to take responsibility for the quality of their work, to help meet company objectives and to assist in resolving quality issues and identifying improvement opportunities.

Scope of job description

The above statements reflect the general tasks, duties, activities and / or responsibilities necessary to describe this position and are not intended to set forth all of the specific requirements of the job.

These job duties/responsibilities may change or vary in response to business needs.