BD (Becton, Dickinson and Company) Manager Quality Engineering-Operations (m/w/d) in Bruchsal, Germany
Job Description Summary
Supervises Angiomed’s Quality Engineering teams for Operations support, CIP/CTW projects and Design to Manufacturing Transfers.
Ensures regulatory compliance and consistency of QA approaches for manufacturing transfers and during the production/distribution phase.
Develops the support strategy and manages QE resources for Design to Manufacturing Transfer projects and for Cost Improvement Projects (CIP/C2W)).
Manages and supports the Operations QE activities during manufacturing transfers and for day-to-day production/process controls.
About the role
As the Quality Engineering Manager (m/w) you are supervising the Operations Quality Engineering teams at our Karlsruhe and Bruchsal manufacturing sites, including staff responsibility for our Operations-QE teams.
You will provide expertise in the areas of quality assurance, regulatory compliance, design to manufacturing transfers, production and process controls, risk management, change controls and statistical techniques.
Provides QE resources for test method development and validation, process validation, statistical data evaluation, component qualification and process capability studies.
Collaborates with the Operations and ME teams for successful implementation of manufacturing transfers, cost improvement and process optimization projects.
Accountable for Quality Engineering (QE) deliverables within the design to manufacturing transfer projects, cost improvement and process optimization projects.
Oversees quality operations activities to ensure conforming materials are available for manufacturing and timely disposition of non-conforming materials
Mentors and develops QE employees and identify their training needs and priorities
Responsible for ensuring compliance to applicable quality assurance requirements as defined by applicable Corporate, international and national requirements and standards (e.g. FDA, ISO, EN, ASTM)
Ensures pre-production QA activities and information are adequately transferred into the manufacturing area during the design transfer process by interfacing with Operations, Manufacturing Engineering and Quality Control groups.
Supports and coordinates the QE related activities for Supplier Management
Supports corrective/preventive action activities, applies root cause analysis and problem solving techniques
Supports change control activities, including QA change impact assessments
Maintains effective reporting systems to support the management reporting and management reviews
You have a Engineering degree required (e.g. in one of the following or similar areas: mechanical engineering, process engineering, material sciences, aerospace industry, automotive engineering, chemical or pharmaceutical engineering). Plus a min. 10 years industry experience in medical device industry or similar industrial environment (areas see above) with good working knowledge of regulatory requirements and quality systems techniques.
Fluent communication in German and English (oral and written)
Manager skill set / supervisory capabilities: ability to motivate and lead staff, high teamwork capabilities, effective reporting
Ability to effectively deal with and negotiate with multi-functional project teams and regulatory authority representatives
Experience in risk-based decision making and problem solving
Good analytical capabilities
Knowledge of project management fundamentals and tool
Knowledge of validation, design transfer and change control principles and techniques
Knowledge of statistical methods and Six Sigma process excellence tools
Knowledge of risk management principles and techniques
Knowledge of root cause analysis, problem solving techniques and CAPA tools
Advanced computer system skills (MS office software, databases and statistical software)
Ability to travel internationally
Working in a highly motivated team in a global environment. A family atmosphere in an innovative environment where your opinion counts. A secure workplace with long-term prospects. We are very anxious for a long-term cooperation - a common career planning along different phases of life is therefore very important to us.
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Primary Work Location
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.