Staff Quality Assurance Engineer New Product Introduction

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Groningen, Netherlands

Job Description:

Johnson and Johnson Vision is recruiting for a Staff Quality Assurance Engineer New Product Introduction located in Groningen, the Netherlands

The Staff Quality Assurance Engineer New Product Introduction provides quality leadership on new product development teams and ensures the Critical to Quality (CTQs) attributes, and cascading requirements are established, implemented and validated.  To ensure partnership with cross-functional stakeholders, the Staff Quality Assurance Engineer will participate as a key member on project teams and/or provide leadership of quality related activities throughout the product life cycle.

Key Responsibilities:

• Provides quality and technical guidance to project teams across various platforms throughout the new product development and transfer lifecycle by ensuring compliance with current quality system procedures including Design Controls, Risk Management, CTQ Flowdown and Supplier Quality.

• Partners with new product development teams to ensure product requirements are traceable to User Needs/Clinical Measures and measurable performance characteristics

• Partners with R&D and manufacturing operations associates to identify areas of risk, and to establish risk mitigation plans for new product introductions

• Collaborates with functional business partners to proactively address quality issues during new product development and product verification/validation, including meeting process capability with respect to product specifications. Leads the quality strategy for the process validation of new product introductions, ensuring that they are well-defined, meet customer needs and are following requirements.

• Supports the development and validation of test methods with R&D partners by verifying their ability to produce consistent, accurate, and repeatable results, ensuring they align with project requirements and standards. This involves evaluating method accuracy via reference materials and validating procedures through documentation reviews.

• Implements system changes to improve the accuracy and efficiency of the new product introduction process

• Participates in product life cycle management activities from product introduction to end of life activities including design changes and audit support.

• In day-to-day activities, adheres to safety and environmental policies and procedures and supports departmental safety and environmental objectives as set by the site and department.

Qualifications

Education:

Education: University / Bachelor’s Degree or equivalent related experience – Engineering / Science / Statistics / Mathematics

Experience and Skills:

Required: Work Experience: 6-8 years of relevant work experience, preferably in the pharmaceutical or medical-device industry

• Strong oral and written communication, interpersonal and organization skills

• Excellent command of Dutch and English language

• Practical understanding and application of principles, concepts and practices of Quality Management Systems, Design Controls and Risk Management, and Product Development.

• General understanding of GMP/ISO, medical device regulation, and design verification / validation / qualification principles

Preferred:

• Experience and knowledge pertaining to MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971

• Certification in Quality training such as CMQ/OE, CQE, CQA, or Six Sigma Black/Green Belt

The anticipated base pay range for this position is 64,000 to 103,040 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:

Preferred Skills:

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