We are looking for a Design Quality Engineer.
The Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
AS a Design Quality Engineer (DQE) you will plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of medical equipment including cooperated with the design and development team, and apply quality management principles throughout the product life cycle.
DQE's main responsibilities include:
Review design documents and specifications, to ensure that they meet relevant standards and regulations
Participant in risk assessment, identify and reduce potential risk quality
Take part in the design and verification process
The Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
AS a Design Quality Engineer (DQE) you will plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of medical equipment including cooperated with the design and development team, and apply quality management principles throughout the product life cycle.
DQE's main responsibilities include:
Review design documents and specifications, to ensure that they meet relevant standards and regulations
Participant in risk assessment, identify and reduce potential risk quality
Take part in the design and verification process
Requirements:
Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
Good ability to comprehend multi-disciplinary systems and processes
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
Ability to work independently with minimal supervision
Computer skills (Microsoft Word, Excel, PowerPoint)
Working knowledge in Statistical Tools, e.g. miniTab (Measurement Systems Analysis, Process Capability and Statistical Process Control)
Knowledge of various quality system methodologies Lean, 5 Whys, DFMEA, PFEMA, PPAP, etc. preferred
Strong written and verbal communication skills
Strong organizational skills
EDUCATION and/or EXPERIENCE:
Bachelor's Degree in engineering or equivalent
At least 4 years of experience in Design quality
Experience from medical device industry – Big advantage
Excellent written and spoken English
Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
Good ability to comprehend multi-disciplinary systems and processes
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
Ability to work independently with minimal supervision
Computer skills (Microsoft Word, Excel, PowerPoint)
Working knowledge in Statistical Tools, e.g. miniTab (Measurement Systems Analysis, Process Capability and Statistical Process Control)
Knowledge of various quality system methodologies Lean, 5 Whys, DFMEA, PFEMA, PPAP, etc. preferred
Strong written and verbal communication skills
Strong organizational skills
EDUCATION and/or EXPERIENCE:
Bachelor's Degree in engineering or equivalent
At least 4 years of experience in Design quality
Experience from medical device industry – Big advantage
Excellent written and spoken English
This position is open to all candidates.
