Staff Quality System Engineer

Responsible for the execution of Quality Systems (QS) at legal manufacturer level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Audit Observations, Product Quality Escalation, Quality System Management Review (QSMR), regulatory submission support and other assigned QS activities to ensure systems are effective and in compliance. Manage the performance and communication of QS metrics at legal manufacturer level. Provides support for special quality projects. Ensures and maintains a state of inspection readiness and Medos international ICQA. Performs in various quality functional areas and maintain expertise.

Section 2: duties & responsibilities

Under supervision and in accordance with all applicable national and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position is responsible of the following activities:

• Act as the Medos International ICQA facilitator and manage on site ICQA (Inter company Quality Agreement)
• Responsible for the timely and compliant execution of site NCs, CAPA, Audit Observations, Product Quality Escalation and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution,
• Manages on site the timely collection, escalation and reporting of all Quality System metrics to management
• Maintains original documentation for site NC, CAPA, Audit Observations, Product Quality Escalation and QSMR as quality records,
• Identifies site needs to meet and improve system performance of NC, CAPA, Audit Observation, Product Quality Escalation and QSMR at the site level, and escalates to appropriate representative and management in a timely manner,
• Leads and participates in quality system improvement initiatives.
• Determines root causes of quality issues and develops corrective action and recommendations for any compliance issues for GSC base business activities
• Establishes, maintains, and implements communications to increase awareness and promote improvement of quality issues across the business.
• Supports compliance activities by participating in audit readiness; assists in Internal and External audits; serves as Subject Matter Expert for NC, CAPA processes
• Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion
• Ensure external and internal audits preparation (strategy level)
• Support the Regulatory department by performing the Legal Manufacturing Final Review of technical documentation
• Lead and review Quality Plans for Strategic Projects
• Support for the management of approved suppliers list in One MD ASL.
• Support as Subject Matter Expert the preparation of the Franchise QSMR: ensure analyze of data and compliance with QSMR procedures and assist the management representative during the meeting by presenting Medos International slides (when requested) and by supporting the meeting minutes creation.

Other support as backup:

• Coordinate regulatory shipping restrictions process and quality restrictions
• Create certificate of analysis process when requested

Qualifications

Education Requirements:

University/Bachelor’s Degree or Equivalent

Experience:

Knowledge / experience of medical or technical industry

• 4 to 5 years of professional work experience within a quality assurance or compliance audit environment is required. Experience working in a Medical Device manufacturing environment is preferred.

• Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred.

Minimum Language required:

French: beneficial

English: fluent

REQUIRED KNOWLEDGE, COMPETENCES, SKILLS, CERTIFICATIONS/LICENSES and AFFILIATIONS

Interpersonal skills / characteristics:

• Ability to communicate at different levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results (negotiation skills)
• Conscientious / Rigorous / Analytical Mind
• Well organized and systematic approach
• Knowledge of Microsoft Office tools

SECTION 5: RESPONSIBILITY FOR OTHERS & INTERNAL / EXTERNAL INTERACTIONS

This position will report to:

Quality Systems Manager - Legal Manufacturing (LM)

This position will include daily connections with all the Medos International Sarl subcontractors (internal and external). This includes but is not limited to :

• Works with other department such as R&D, Deliver, Regulatory affairs or Record management to ensure that a variety of business transactions are completed
• Manage the Management Review
• Host business meetings with other functions
• Participate to internal and external audits
• May act as back up of Quality System Manager – if required
• Approval / rejection of change notices
• Approval / rejection of CAPA and NC (additional approver, reviewer)
• Administrator of EtQ CAPA database and CAPA facilitator
• Administrator of EtQ NC
• Approval / rejection of ERP tasks linked to Regulatory restrictions
• Approval Suppliers Management in One MD ASL (For J&J sites : Medos international Le Locle Switzerland, Mitek Neuchatel Switzerland, Spine Le Locle Switzerland)