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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Amersfoort, Utrecht, Netherlands

Job Description:

Key Responsibilities:

• Be the main point of contact for quality and compliance aspects for EMEA Service Centers

• Ensure general compliance support for consistent and correct execution of QS procedures at all Service Centers e.g. change management strategies

• Be the subject matter expert for the validation of equipment and computer system validation of equipment

• Ensure qualification and management of Suppliers related to Installation & Servicing

• Collaborate with Service Operations to ensure global harmonization of service processes.

• Collaborate with Customer Quality representatives to ensure compliance with reporting requirements of all Service centers and accuracy of service evaluations linked to customer complaints

• Support tracking of monthly performance and quality metrics for each Service Center and attend the monthly/annual review meetings

• Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Servicing for the Netherlands Service Center and regional QMS

• Collaborate on shared/global procedures update and harmonization

• Support Service Sites internal and external audits based on sites requirements

• Conduct training related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified at the sites.

• Manage the initiation and review of Service Level Agreements

• Responsible for communicating business related issues or opportunities to the next management level

• Conduct data driven analysis based on requirements

• Lead continuous improvement initiatives to ensure efficiency, effectiveness, and compliance

• Maintain awareness of ISO standards while developing solutions to satisfy business needs

Required Qualification and Core Competencies for the role:

• Bachelor degree in engineering, scientific or quality and compliance disciplines. Will accept the equivalent relevant industry experience in the absence of a degree

• At least 5 years experience in Quality (medical devices and validation of equipment preferred)

• Recommended Lean six sigma Green/Black belt, Project Management Certification will be an asset for this position

• Experience in regulated ISO 13485 industries

• Excellent communications skills

• Organizational skills, ability to resolve conflicts

• Strong analytical thinking skills and the ability to work in a flexible way under time pressure in local and global teams

• Ability to make risk based decisions under time pressure

• Understands the business implications regarding quality positions and decisions

• High sense of responsibility and reliability

• Work independently within established timelines

• Experience with ETQ, Windchill and MD S&R will be beneficial

• Fluent in English

• Ability to travel if and when required

"Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.”

The anticipated base pay range for this position is 62,600.00 to 100,970.00 on an annual basis and includes 8% holiday allowance

 In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

 

 

Required Skills:

Corrective and Preventive Action (CAPA), Quality Control (QC), Quality Validation

 

 

Preferred Skills:

Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)