Quality Manager/Director

3 weeks ago

india MB&A Full time
Job Description

Summary:

We are seeking a dedicated Quality Manager/Director to join a team for a leading contract manufacturer specializing in orthopedic and trauma implants in Holland, Michigan. If you are passionate about shaping and elevating quality standards in a dynamic environment, we invite you to be a key player in our ambitious quality management team.

Responsibilities:

As a Quality Manager/Director, you will play a pivotal role in the development and implementation of quality management systems, ensuring compliance with EN ISO 13485, 21 CFR Part 820, and ISO 14971 for risk management. Your responsibilities will include:


  • Continuous improvement and application of quality management systems, collaborating with various departments.
  • Oversight of the CAPA system for internal and external complaints.
  • Planning, execution, and follow-up of internal and external audits.
  • Designing process and quality improvements, and coordinating change management.
  • Creation, implementation, and monitoring of corrective measures, aligning with market and customer requirements.
  • Coordination and leadership of the Quality Management (QM) team, fostering motivation, and professional development.
  • Serving as a sparring partner and supporting team members in problem-solving.

Management Responsibilities:

As the head of the Quality Management department, you will:

  • Professionally lead the QM team.
  • Motivate and develop team members, fostering a culture of top performance through fairness, honesty, and trust.
  • Proactively take responsibility for activities, delegate effectively, and provide support during challenges.
  • Communicate clearly and precisely, guiding and motivating employees, resolving conflicts competently, and delivering constructive feedback.

Quality Management Responsibilities:

You will be responsible for:

  • Developing, optimizing, and systematically applying management systems (EN ISO 13485, 21 CFR Part 820, EN ISO 14971) and ensuring regulatory compliance.
  • Initiating and implementing concepts and procedures for process and quality improvement, coordinating change management.
  • Planning and implementing validation and qualification of production facilities.
  • Supervising the introduction of new processes and their documentation in the quality management system.
  • Designing CAPA systems for processing internal and external complaints, and initiating corrective and preventive measures.
  • Coordinating customer complaints, supporting error analyses, process optimizations, and initiating corrective measures.
  • Planning, implementing, and meticulously following up on internal and external audits.
  • Preparing and reviewing quality agreements and supplier declarations with suppliers and customers.
  • Creating, initiating, processing, and monitoring corrective measures, and organizing the quality area according to market and customer requirements.

Requirements

Qualifications:

To excel in the role of Quality Manager/Director, we are seeking candidates with the following qualifications:


Education:

  • Bachelor's degree in a relevant field; advanced degree preferred.
  • A technical degree or equivalent training with practical experience, ideally related to ISO 13485.

Experience:

  • Extensive experience in quality management, including leadership roles.
  • Experience in machining processes and a strong background in Quality Management.

Skills:

  • Strong understanding and application of relevant standards and regulations (EN ISO 13485, 21 CFR Part 820, EN ISO 14971).
  • Methodological skills for root cause analysis and problem-solving (e.g., 5-Why, Ishikawa, brainstorming).
  • Proven ability to lead and motivate teams, with excellent communication and conflict resolution skills.
  • Experience in developing and optimizing management systems and implementing change management processes.
  • Solid knowledge of validation and qualification processes for production facilities.
  • Familiarity with CAPA systems and handling customer complaints.
  • Excellent communication skills and high-quality standards.
  • Ability to communicate effectively at a high technical level.

Attributes:

  • Team spirit while maintaining a focus on individual results.
  • Analytical thinking and fact orientation.
  • Excellent organizational skills and attention to detail.
  • Strong analytical and problem-solving capabilities.

Requirements
Knowledge of regulatory requirements, particularly in qualification, validation, and manufacturing guidelines for medical devices (DIN ISO 13485, 21 CFR Part 820, GMP Annex 15, DIN EN ISO 14971). Desirable knowledge in the validation of computerized systems and software (21 CFR Part 11, GMP Annex 11, GAMP 5).

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