Senior Quality Assurance Engineer

3 weeks ago

Greater London, United Kingdom Meet Full time

SENIOR QUALITY ENGINEER JOB DESCRIPTION

POSITION: Quality Assurance

DEPARTMENT: Quality

REPORTS TO: Head of Quality and Regulatory

Based near to Bracknell


The Quality Engineer works closely with various stakeholders at all levels of management and needs to understand critical to quality design characteristics/specifications; and performs reviews and release of Notified Body MDR Submission packages, and project management of all Quality SOPS and Records within the QMS, including DHF documentation, ensuring the products comply with mandatory Quality & regulatory requirements (UK, EU, USA/FDA etc.).


The candidate will help create, monitor, and drive robust smart lean improvements of ISO 13485 and 21 CFR 820 quality system procedures to ensure compliance requirements are met efficiently and effectively and in support of

Quality and company objectives.


We are looking for passionate individuals, who are agile, resilient, take responsibility for their development and focus on achieving excellence. We provide an environment for Forward Thinkers, Game Changers and Team Players to thrive in. If you enjoy collaboration and working in diverse and international teams, never compromise on quality and always act responsibly remembering that our customers come first, we would love to hear from you.


Duties include:

  • Quality assurance support in the design and development support of medical device products/software/APPs, facilitating application of design/change controls, risk management, quality plan, and implementation of design and development plan.
  • Act as Quality SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation, Usability, Reliability & Repeatability, etc.
  • Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 20) and other applicable standards.
  • Quality oversight of internal and external process characterization project plans, protocols, and Reports, including selection and control of outsourced Critical Suppliers for a virtual Device Company.
  • Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21 CFR 820.
  • Knowledge of cGMP, GDP. GdP, GCP, UK-CA FDA/EMA-EU regulations (EU-CE).
  • Support regulatory inspections by FDA and foreign regulatory agencies, including outsourced Critical Supplier (CMOs) and internal & external warehouses.
  • Applying best practices/SOTA to ensure high quality and reliable products.
  • Designing Quality Standards: They develop and implement quality standards for medical devices, ensuring compliance with regulatory requirements.
  • Inspecting Materials and Processes: They inspect materials, equipment, and processes to ensure they meet quality standards.
  • CAPA Quality SME in identify quality issues and implement containment, corrections and corrective actions to resolve them.
  • Basic understanding on Regulatory requirements of global regulatory requirements and standards.


Experience, skills and education:

BS in Engineering (or equivalent) and/or a minimum of 6 years' experience in the regulated medical device industry as a Quality Assurance Engineer supporting new product development and within a manufacturing, environment preferred.


Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality

System Regulations, Good Manufacturing Practices, Good Documentation Practices


Working knowledge of principles, concepts, and practices for design and development activities, Risk Management, FDA 510K submissions, and ISO Regulations, including 6 Sigma training & qualification, green belt or above. EDM experience preferred.


Quality Management: Proficiency in quality management systems (QMS), including experience with tools like statistical process control (SPC), design of experiments (DOE), and root cause analysis.

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