Quality Manager

Quality Köln, Germany


Description

At our Cologne office we are currently looking for a:

Quality Manager (m/f)

MAIN RESPONSIBILITIES/DUTIES

  • 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.


REQUIREMENTS/QUALIFICATIONS

ACADEMIC BACKGROUND

Have Engineering / Quality Management degree or equivalent training is a must.

REQUIRED EXPERIENCE

  • 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.

LANGUAGES

  • 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).

SKILLS /COMPETENCIES

  • 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.

SPECIFIC CERTIFICATIONS/SPECIALTIES/COURSEWORK

  • 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.

SUPERVISORY RESPONSIBILITIES

  • Document control specialist