About the Role
The Sr. Sustaining Quality Engineer will be responsible for ensuring the manufacture of high-quality medical devices by ensuring compliance with critical quality requirements, working closely with the operations team to define process controls, process validation requirements, and in-process inspections.
Key Activities
Plan and execute quality-related maintenance and improvement activities related to devices, as well as the qualification of in-house materials to prevent or minimise quality issues.
Develop and improve manufactured supplied parts inspection strategies based on the establishment, implementation and improvement of related quality metrics and monitoring of critical to quality indicators.
Collaborate with the Operations Engineers to determine the qualification and requalification activities for equipment qualification and process validation, process capability, test method validation and ISO 14971 risk management activities and process improvements.
Lead CAPA and NCMR investigations and support investigation teams relating to product functionality and design improvement.
Communicate effectively with internal counterparts regarding product-related CAPA and other quality issues.
Evaluate the impact of proposed component, product and process change requests; lead cross-functional teams to identify and execute appropriate actions.
Facilitate compliant and timely process deviation, change control and quality planning activities.
Identify, propose and drive opportunities for improvement, including review and revision of procedures and associated documents. Support other quality system activities as directed by management.
Preferred Skills
ASQ Certified Quality Engineer, preferred.
Proficiency in leading CAPA and nonconforming product investigations.
Education and Experience
BA/BS Engineering-oriented degree and 5+ years of experience in medical device manufacturing.
Understanding and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management, and production and process controls.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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