HireDiversity

Zuchwil, CH

Europe Quality Systems Manager-000008XM

Description

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

JOB PURPOSE:
Provide ongoing strategic review and continuous improvement of the Legacy Synthes Quality System in line with Franchise and Sector standardization initiatives utilizing robust project management methodologies. Actively engage in quality system management activities in terms of product safety, field action management, quality system and compliance improvement, inspection management, business solution innovation, and customer facing quality improvement opportunities.

MAIN DUTIES & RESPONSIBILITIES:

• Develop and drive improvement in the Quality System supporting the Global Orthopaedic organisation specifically CAPA, NCR, Management Review, Internal Audit, Escalation, Trending, Risk Management, Quality Planning and Failure Investigation.
• Carry out strategic planning and development process on a continuous basis, analysis, definition and PMO leadership.
• Identification and leadership of tactical continuous improvement opportunities
• Collate and analyze the relevant information through Management Review to facilitate a review of the performance and suitability of the QMS.
• Collaborate with business partners to develop and implement innovative business solutions
• Carry out quality system due diligence and integration activities as required by the business
• Active engagement with external regulatory authorities, including performing lead and support roles as required for Legacy Synthes QA during external inspections.
• Provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies in Global Orthopaedics.
• Partner on the formulation of responses to regulatory agencies in order to address QMS related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions.
• Standardize and leverage MD&D compliance policies, practices, metrics and resources across the sector in alignment with the enterprise standards.
• Ensure emerging regulatory requirements are addressed in a proactive and effective manner
• Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings.
• Support Global Orthopaedics objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure
• Develop Quality Organisation Structure to support EU Legacy Synthes Quality Management System.
• Ensure effective recruitment/organizational development for all direct reports.
• Perform financial planning and overall budget management
• Perform all other work related duties
• Represent Quality as required on quality and business teams throughout Global Orthopaedics and MD&D.

Qualifications


KEY COMPETENCIES REQUIRED:

• Demonstrated leadership ability
• Excellent communication skills - Both verbal and written
• Strong collaboration and influencing skills - Both Internally and Externally
• Team building and development capabilities
• System design and management skills - Organizational and Quality Systems
• Expert knowledge of the US Quality System Regulations and ISO 13485
• Demonstrated track record of delivering best in class results in the Quality Systems area

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• 10+ years Quality Systems Experience - ISO 13485 and QSR Regulated Industry
• 5+ years Quality Systems Management Experience - ISO 13485 and QSR Regulated Industry
• Broad based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance
• A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
• Experience in auditing to FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
• Demonstrated knowledge of business impact of compliance issues and risk management
• Demonstrated effective people management in multiple locations
• Experience in preparing for & managing external third party audits in multiple locations

DESIRABLE:

• Degree in Engineering/Scientific or associated relevant technical / Quality discipline
• Masters degree in Quality / Regulatory preferred
• Process Excellence Black Belt Certification
• Strong compliance management track record

Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Organization: Medos Sarl (8575)
Job Function: Quality Systems