At our Cologne office we are currently looking for a:
Quality Manager (m/f)
- Identify and lead the implementation of continuous opportunities of improvement (process and/or quality) focused on exceeding customer needs.
- Participate, as required, in the corporate Internal & Supplier audit program.
- Ensure Quality Systems activities are implemented and maintained to satisfy FDA GMP/QSR, ISO 13485 and applicable worldwide regulatory requirements
- Supervise that CAPA and Internal Audits processes are effectively working at the German site.
- Be involved, as needed, in any Corporate or outside agency inspections relating to Quality Systems and act as a Quality Management Representative for the German site (DE).
- Lead and coordinate all the preparation and hosting activities related to any Corporate or outside agency inspections to the DE Quality System.
- Identify and manage projects to improve the effectiveness of the quality system
- Escalate nonconformities in the Quality System to upper management where appropriate.
- Establish quality system related procedures and policies
- Work with Production, Engineering, Clinical, Training, etc. on compliance and QMS improvement activities
- Perform quality system related training to the organization as needed
- Supervise that customer complaints for the Treat Operation are addressed and that corrective actions for trending causes are taken.
- Supervise effectiveness of the internal audit sub-system at the Treat Operation.
- Supervise the Documentation Services and Learning Management System (Align University) areas for the DE site.
- Lead internal and cross-functional teams in quality improvement efforts.
- Responsible for identifying issues that need corrective action.
- Establish key quality metrics and develop collection, analysis, and reporting systems, which promote timely communication and corrective action
- Perform quality related training to the organization as needed
- Ensures the effective fulfillment of objectives and deadlines assigned to the group.
- Participate in proactive team efforts to achieve departmental and company goals.
- Perform other duties as assigned.
Have Engineering / Quality Management degree or equivalent training is a must.
- 5-year minimum experience working in Medical Device, Pharma or life science Quality Management position is required.
- 3-year minimum experience in supervisory or managerial roles
- Extensive Internal Auditor experience in performing internal quality audits.
- Knowledge of applicable Quality System regulations, such as GMP/QSR and ISO 13485.
- Strong written and oral communication abilities required and ability to synthesize information to present as requested.
- Fluent English and German required (reading, writing, and conversation).
- Must have good interpersonal skills and the ability to work cross-functionally.
- Must have exceptional problem-solving and decision making skills
- Must have a full grasp on statistical methods and techniques – must think analytically and in a data-based fashion.
- Must have exceptional level of commitment and a positive can-do attitude.
- Must be able to make good assessments on what can and cannot be accomplished before making commitments.
- Must be proficient with computers and standard software programs such as Microsoft programs and Minitab
- Must be able to work independently as well as in close collaboration with others.
- Ability to do research and come up with creative, compliant solutions for quality system challenges
- Demonstrated leadership; attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects.
- Training on statistical techniques is a plus.
- Certified as an Internal Auditor.
- ASQ Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt are a plus.
- Document control specialist
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