Senior Quality Engineering Specialist - Medical
At Celestica, we value quality above all else. We are committed to raising the bar and exceeding our customers’ expectations.
- We never settle. With an uncompromising focus on quality, we deliver industry-leading products and services that meet all applicable customer, statutory and regulatory requirements on time, every time.
- We leverage our leadership. We apply our leadership in technology and manufacturing to drive the relentless pursuit of defect-free performance.
- We’re nimble problem solvers. Our customers’ needs and conditions are constantly evolving. We quickly adapt to change and drive unique value for our customers through continual improvement and the elimination of waste.
- We hold ourselves to the highest standard. We’re committed to improving and maintaining an effective quality management systems as a framework for setting quality objectives that support the company’s strategic direction.
Responsibilities:
- drives the Quality aspects of a new Health Tech Customer (HTC) or New Product Introduction;
- participates in releasing Quality Plans, Control Plans, First Article reports;
- creates, publishes, reviews, controls and constantly improves process documentation;
- develops, maintains, and communicates Change management processes in conformance with ISO, Food and Drug Administration (FDA) standards, Medical Device and Diagnostics standards and regulations, and Customer’s requirements;
- initiates and participates in an annual review process to ensure data integrity and revises existing documentation to reflect process changes;
- collects data/information releasing analysis and reports;
- acts as the lead auditor for Internal Quality System Audits. Plans, directs, performs, and reports the results of process, product, systems, supplier, and ISO quality audits;
- acts as contact person in external second party or third party audits in the team of the Management Responsible for the audited systems;
- performs independent, comprehensive reviews of the existence, correctness and effectiveness of standards and controls used to perform specific functions;
- develops, documents, and monitors key processes such as the Design Transfer and Validation Process, Corrective Action Process, Audit Process etc.;
- provides consultation and training in the areas of Health Tech Quality requirements, Quality Tools, Statistical Process Control, Risk Management, Workmanship, PCA skills, standards, audit, etc.
Requirements:
- Bachelor’s degree in related field;
- Usage of computer (Office, Minitab etc.);
- Good command of written & spoken English;
- knowledge and experience in Health Tech (ISO 13485, EU MDR/IVDR and FDA CFR 821/210/211 regulations);
- strong understanding of quality systems;
- good analytical and problem solving skills;
- ability to exercise good judgment in implementing change orders that affect pricing, costs, and manufacturing processes;
- ability to effectively communicate with a wide variety of internal and external customers;
- five to seven years’ relevant experience in Quality Engineering role I Medical Device and In Vitro Diagnostics manufacturing environment is essential;
- involvement with FDA inspections and In Vitro Diagnostics experience is essential
- high level teamwork player, resistant to stress/critical situations;
- ability to prioritize and problem solve a variety of tasks to ensure their timely and accurate completion;
- ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers;
- working knowledge of engineering and supply chain systems, inventory management and planning process is an advantage;
- Lean Six Sigma knowledge is advantage;
- Lead Auditor experience and/or certification is advantage
- Strong basic technical knowledge is advantage.
- Minimum of 5-7 years’ experience in a Quality Engineering role in Medical device manufacturing environment is essential.
- Degree qualification minimum in a related field – essential.
- Involvement with FDA inspections as the Quality Lead is desirable.
- Lead Auditor conducting Quality Audits essential, with experience of ISO/FDA/HPRA audits highly desirable.
- Experience of 6 Sigma methodology. Ideally a 6-sigma black belt.
- Project Management Training/Experience – an advantage
COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) is a US$5.6 billion global leader in the delivery of end-to-end product lifecycle solutions. Our customers trust us to deliver the most advanced design, engineering and manufacturing expertise for their highly sophisticated and complex products. From advanced medical devices, to highly engineered aviation systems, to next-generation hardware solutions for the Cloud, at Celestica we manage the complexity for our customers and set the bar for quality and reliability in their markets. Our customer portfolio includes leaders in the enterprise computing, communications, aerospace and defense, industrial, smart energy, healthtech and semiconductor markets. Headquartered in Toronto, our global network spans 13 countries with 26,000 employees throughout the Americas, Europe and Asia.
