Applies quality engineering principles and techniques to ensure that the products developed and manufactured by the division meet or exceed performance specifications and regulatory standards.
Quality Engineer: Medical Device: South East
Applies quality engineering principles and techniques to ensure that the products developed and manufactured by the division meet or exceed performance specifications and regulatory standards. Works within the Quality Operations Group to support manufacturing and provide decisive, scientifically based solutions to process problems and to support process improvement.
- Utilizes quality engineering methods to ensure that the product design is transferred into manufacturing processes that are capable of reliably delivering products that are safe and effective and consistently meet the performance requirement
- Ensures that the division complies with all applicable procedures, regulations and standards during the development and manufacture of its medical device products
- Applies risk management, change control and validation principles and techniques throughout the product lifecycle (from development over design transfer to manufacture and distribution)
- Applies and improves procedures for consistent and effective implementation of quality system and regulatory requirements in the area of responsibility
- Participates in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non-conformances so that issues are resolved to close out with no recurrences.
- Ensures compliance to quality system requirements as defined by procedures, FDA QSR, ISO 13485 and applicable international and national standards (e.g. EN, ASTM) through active participation in the divisional and cross divisional product and process development system
- Provides Quality Engineering representation on cross-functional product development teams
- Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance
- Leads cross-functional teams to develop risk assessments and risk controls
- Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods
- Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups
- Applies risk management, change control, and validation principles throughout the product lifecycle
- Supports the divisional corrective / preventive action program by applying root cause analysis and problem solving techniques and by implementing corrective/preventive actions
Education and Experience:
- Min Engineering or Science degree required
- Experience in medical device industry or similar industrial environment (areas see above) with good working knowledge of regulatory requirements and Quality Systems techniques
- Experience in risk-based decision making and problem-solving
- Good analytical capabilities
- Knowledge of design validation, design transfer and change control principles and techniques
- Knowledge of statistical methods and Six Sigma process excellence tools
- Knowledge of risk management principles and techniques
- Knowledge of pre-production QA principles and techniques (e.g. APQP, PPAP, MSA)
- Knowledge of supplier qualification and management principles and techniques (incl. auditing techniques)
- Knowledge of project management fundamentals and tools
- Advanced computer systems skills (MS Office software, databases and statistical software)
- Good teamwork capabilities, effective reporting
- Fluent English communication skills (business English written and oral)
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.