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Job Description
Quality Operations Engineering Manager sought to support operations expansion in Galway city.
Our client, a major multinational, requires a Quality Operations Engineering Manager to oversee quality management systems and enable achievement of quality objectives. The role involves managing and supervising professional employees performing diverse roles within the quality function or unit.
Key responsibilities include:
- Providing direction, coordination, and tools to achieve and maintain the site Quality Management System and enable the achievement of quality objectives.
- Supporting generation of performance metrics for products and processes of moderate complexity, and driving the team to achieve Quality Goals set by management following industry standards such as ISO, IPC, AS, TL.
- Leading Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex.
- Directing and influencing the preparation of documentation to support high-quality regulatory submission dossiers.
- Supporting regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
- Acting as company representative, developing and maintaining positive relationships with device owners through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Mentoring and training personnel in the practices of Quality management and Quality improvement (succession development).
- Resolving customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely.
- Providing 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).
- Supporting 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.
Requirements:
- Minimum 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.
- 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), 5 S 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 Power Point.
- Excellent knowledge of the manufacturing processes.