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Project Manager Quality Assurance
Covidien is a leading manufacturer, distributor, and servicer of medical devices worldwide. Its broad portfolio includes disposable medical supplies, monitoring equipment, medical instruments, as well as bulk and dosage pharmaceuticals. These products are sold under such names as Autosuture, Kendall, Mallinckrodt Nellcor, Puritan Bennett, Syneture, United States Surgical, Valleylab, and others. Covidien manufacturing operations consist of over 60 manufacturing facilities worldwide, utilizing diverse technologies to support a broad portfolio of products.
The Global Operational Quality position aligns to the quality leadership team and is established to support the improvement and consistency of the quality practices throughout the 60 plants in Covidien. Our goal is to create world class manufacturing practices through a focus on SPC, lean manufacturing, quality assurance; knowledge based management, six sigma and data-based decision making.
Summary of Position
This position is for a Quality Assurance Project Manager with significant experience and proven success in world class manufacturing and operational quality. Candidate should demonstrate experience with international suppliers and quality management concepts, including but not limited to risk analysis, statistical process control, root cause investigations, CAPA, supplier quality and continuous improvement. The Quality Assurance Project Manager will directly support the emerging markets sourcing strategy through coordination and execution of supplier management activities supporting multiple the global business units.
The Quality Assurance Project Manager assists in the leadership of cross-functional teams that can apply tools to analyze and improve quality operations, compliance and knowledge based management practices throughout the organization and effectively drives change. The position will be expected to provide support and direction in quality systems management and compliance. The intent of the position is to leverage the operational experience of the person to benefit the world wide manufacturing operations of Covidien
This position offers exposure to multiple manufacturing sites with diverse processes and healthcare product portfolio, and best practice training in manufacturing operations and project management. The person will assess and improve critical manufacturing processes and obtain valuable corporate operations experience, in preparation for assignments in Manufacturing, Engineering, Quality and Procurement areas of Covidien.
Requirements:
Education required/preferred:
- BS/BA in science or engineering/MBA or MS in engineering preferred
Experience:
- Minimum 5 years relevant experience managing quality in a manufacturing environment
- Working knowledge of and auditing experience to GMP, ISO 13485 and ISO 14971 regulations preferred
- Exposure with managing and leading supplier development activities
- Experience with international suppliers
Preferred Skills/Qualifications:
- Lean Manufacturing certification, Six Sigma Black Belt, Six Sigma Green Belt, project management, Quality Engineering tools
- Experience with PPAP/APQP concepts
- Quality Assurance experience in manufacturing environment (preferably in a FDA environment).
Skills/Competencies:
- Project Management skills
- Proven ability to directly lead and/or co-lead multiple high-impact process improvement projects
- Working knowledge of quality system regulations, GMPs and ISO requirements
- Must be a change agent
- Proven ability to coach and mentor others
- Excellent verbal and written communication skills
- Ability prioritize and a fast-paced, changing environment
- Ability to identify root cause and implement long term solutions
- Solid conflict resolution skills
- Working knowledge of Quality Tools (Advanced Statistical Techniques, Technical Writing, Inspection and Testing, Sampling Principles and AQL, TQM, Six Sigma, Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, Pareto Analysis, etc.)
- Working knowledge of Quality Systems, Auditing, Engineering, GLP, Quality System Regulation and ISO Requirements
Responsibilities
- Travel to manufacturing sites to drive continuous improvement
- Provide expertise in Supplier Quality (selection, evaluation, risk assessment, agreements, evaluation, corrective actions, supplier quality metrics, etc)
- Act as the liaison between Corporate Sourcing, Corporate Quality and international resources to support emerging markets sourcing strategy.
- Lead a highly skilled team that will work with manufacturing sites to assess and improve critical manufacturing and quality processes
- Provide expertise in supplier development, risk analysis, process control, root cause investigations, visual quality management and continuous improvement
- Identify and implement improvements in areas of continuous process and manufacturing improvement
- Interact and form constructive working relationships with all level of leadership within manufacturing, procurement, engineering and quality operations
- Utilizes coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting and best practices utilized
- Travel 25% - 50% with emphasis on international
- Office location: Mansfield, MA
To apply online, please use the following link:
Apply To Covidien
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