Quality ManagerDate: Aug 2, 2024
Location: Galway, G, IE
Functional Area: Quality (QUA)
Career Stream: Operations Quality (OPQ)
Role: Manager 1 (MG1)
Job Title: Manager, Operations Quality 1
Job Code: MG1-QUA-OPQ
Job Level: Band 09
Direct/Indirect Indicator: Indirect
SummaryDetailed DescriptionYour next challenge will be to…
Support generation of performance metrics for products and processes of moderate complexity, and drive the team to achieve Quality Goals set by management (i.e.: DPQL, Total Quality at Celestica (TQ@C)), following industry standards such as ISO, IPC, AS, TL.Lead Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex.Direct and influence the preparation of documentation to support high quality regulatory submission dossiers.Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.Act as company representative, developing and maintaining positive relationships with the device owners through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.Mentor and train personnel in the practices of Quality management and Quality improvement (succession development).Resolve customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely.Provide leadership and support in a variety of areas such as analysis of nonconforming materials and customer return material authorizations (RMA's), supporting customer and 3rd party audits, and the administration of Quality management (Documentation, Change Control, Corrective & Preventive Actions and Calibration).Support new customer qualification and New product introduction with supplier assessments, First Article Inspections and oversee generation of product documentation for products/programs of moderate risk.What do we expect from you?In-depth knowledge of quality metrics, ISO standards and processes.Knowledge of Lean and Six Sigma Manufacturing processes and controls including: Statistical Process Control (SPC), 5S and Value Stream Mapping (VSM).Strong knowledge of Quality Management tools including: Failure Mode and Effect Analysis (FMEA) and development of Quality Control Plans.Ability to coordinate a wide variety of resources to meet production quality and quantity metrics.Ability to effectively communicate with a wide variety of internal and external customers.Ability to effectively lead, manage, train and motivate a diverse group of employees to achieve high production levels within tight time deadlines and in a highly dynamic manufacturing environment.Ability to use some or all of the following PC applications: Google Applications, Word, Excel, and PowerPoint.Excellent knowledge of the manufacturing processes.Typical ExperienceMinimum of 7-10 years' experience in a Quality role.2 – 5+ years regulatory affairs experience or related experience in medical device industry and/or Pharmaceuticals is required.Working knowledge of FDA and international regulations.Experience working directly with FDA, notified bodies and/or international health authorities is desired.Degree qualifications (NQF L8 or L9) minimum in a related field or consideration of an equivalent combination of education and experience.Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
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