Commercial Quality Specialist Netherlands, Orthopedics

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Job Summary:

Maintains quality records on product testing nonconformance project outcomes and stakeholder input filed in an accurate and timely manner. Coordinates change control documentation and approval process. makes proposals and assists in the development of corrective action plans and monitors implementation. Follows up on closure of corrective and preventive actions. Provides quality support for technology transfer and improvement of existing manufacturing processes. Conducts investigations collects data analyzes trends and prepares reports for assigned quality processes. Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time. Prepares for and facilitates audits and inspections. Monitors trends identifies issues recommends and implements appropriate actions. Assists in the development implementation and review of standard operating procedures for interactions with contract manufacturers.

Additional info:

Johnson & Johnson Medical BV is recruiting for a Commercial Quality Specialist located in Amersfoort.

As a Commercial Quality (CQ) Specialist you will run the Quality Management System (QMS) for the Medtech organization in the Netherlands. You will collaborate closely with the CQ manager the CQ specialist in Belgium the local distribution center and local sales & marketing organization in order to keep up with quality & compliance requirements. You will be part of the CQ Benelux team.

Key Responsibilities:

The position is accountable for the oversight and execution of Quality Management Systems and compliance at CQ Organization in Benelux that receive pick pack store inspect repack/relabel and deliver Orthokit loaner operations and finished goods like Human Tissue to customers.

The position serves as a single point of contact to the corresponding Distribution (Netherlands) and Customer Service (Benelux) activities for Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

The position implements departmental strategies and services as the business expert on quality systems distribution and quality collaboration with Enterprise Commercial Quality and other segments implement common distribution and loan kit standards and Quality Management Systems (where appropriate).

The position optimizes quality systems and processes and ensures alignment with the worldwide business applicable local regulations & J&J Enterprise standards the quality vision and/or Policy and provides a measurable impact to quality cost and customer value. The position identifies opportunities to continuously improve quality cost and time factors consistent with both Segment and business objectives. Identifies significant business issues prioritize for action and support improvement opportunities and problem solutions. The position maintains understanding and awareness of current and emerging regulations and the impact to quality and distribution practices.

The position plans coordinates and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

Qualifications

Education:

• Bachelor or equivalent in business experience

• Preferably with knowledge on Quality Management Systems and/or Healthcare industry

Experience and Skills:

Required:

• Previous Quality and/or Regulatory experience

• Ability to connect and effectively collaborate across a diverse group of business and quality team members both locally and on an EMEA-level

• Good interpersonal skills & influencing skills

• Driven by results performance & excellence in the job

• Ability to build respect and trust with customers employees and internal collaborators

• Self- awareness and adaptability

• Quantitative skills and process oriented

• Experienced in training of employees / teams

• Eye for Good Documentation Practices and Data integrity

Preferred:

• Knowledge of Quality Management systems (ISO 13485)

• Operational experience in the healthcare industry

• Experience working for a mid-size or multinational company

• Internal ISO auditor certificate

Other:

• Language requirements: fluently in English and Dutch

• This is an office based job (location Amersfoort).

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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 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 53500 EUR to 85445 EUR 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 locations 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.

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