Our client had developed a novel approach to treating cancer by using a highly sophisticated technology allowing greater access to cancerous cells in a far less invasive method than previously available. If you are a Senior Quality Engineer looking to join a dynamic team of innovative professionals and are passionate about your work and improving people’s lives, look no further!
Senior Quality Engineer – product development of complex Class ll medical device capital equipment
The Senior Quality Engineer will work as a member of a cross-functional project team engaged in new product development. The individual will serve as the primary quality representative focused on design assurance and will work closely with the development team. This individual will be responsible for ensuring that the product development project is executed and released meeting customer expectations, regulatory requirements, appropriate voluntary standards and all internal policies and procedures. This role will be a key member of the product development team and will have the opportunity to influence the product design direction based on the customer needs and product safety, quality, and reliability requirements and performance.
Key Duties and Responsibilities:
Integrate with the product development team, serving as the Quality Assurance representative.
Responsible for reviewing development ECOs, participating in design reviews, evaluating risk mitigation activities, planning and performing verification and validation tasks, and managing supplier approvals.
May assist with other Quality Department tasks including incoming and in-process inspection, maintaining identification and traceability throughout production, equipment qualification, preventive maintenance and calibration, internal auditing, nonconforming materials resolution, and training.
Reports to the Director of Quality Assurance and Regulatory Affairs.
Other duties as needed or assigned.
Excellent knowledge of design controls and 21 CFR 820, ISO 13485, ISO 14971, and other applicable medical device standards, guidance documents, and regulations.
Demonstrated ability to make critical decisions regarding product quality and quality system compliance.
Understanding of basic electrical/mechanical/materials/software engineering principals.
Thorough understanding and track record of implementing root cause tools and techniques, including DMAIC.
Proficiency in risk analysis techniques (e.g. fault tree, FMEA, Safety Assurance Case) and experience leading others through process mapping exercises and coaching others in problem solving.
Ability to assess and articulate risk when evaluating a situation.
Excellent knowledge of equipment qualification and process validation, including software tool validation.
Professional certifications (CQE, CQA, CRE) are desirable.
Basic time management, organizational, and prioritization skills to successfully complete job duties and responsibilities in a timely manner.
Basic problem-solving skills and ability to resolve problems in a timely manner.
Basic communication and presentation skills to properly communicate relevant information to peers.
BS degree in engineering.
Seven years minimum of Quality Engineering experience in the medical device industry, including directly supporting new product development.
Class II medical device experience required, including complex capital equipment.
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