Quality Manager - Engineering (m/w)
Job Description SummarySupervises 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 New Product Development (NPD) projects and for Cost Improvement Projects (CIP).
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.
Are you interested in a career at BD, but this position does not match your skills and expectations? Then join our external EMEA Talent Community now: http://bd.tal3nt.community/
Primary Work LocationDEU Karlsruhe
Additional LocationsDEU Bruchsal
Recommendto a friend
"I like being able to make a difference. Working at BD is an opportunity where the products save lives every day."
Current Employee - Anonymous, Limerick