The Associate Director, MedicalDevice & Combination Product Quality Assurance reports to the Director of MedialDevice and Combination Product Quality (MDCPQ) and is responsible forindependent compliance support of Medical Devices including the deviceconstituent part of Combination Products. This position will interact withcross functional teams working with all levels of employees. Activities willinclude developing, documenting, and maintenance of technical businesssolutions or audits of data, policies, procedures, and systems to ensurecompliance with Medical Device (21CFR 820s) and Combination Product currentGood Manufacturing ruling (21CRFT part 4.) Device Risk Management (ISO 14971)and other worldwide regulations and MSD Requirements.
The primary purpose of this position is to provide Device Quality Assurancesupport and leadership to ensure sustaining/remediation activities andsuccessful quality oversight of prospective combination products. The AssociateDirector will be expected to apply his/her knowledge of product development,design control principles, risk management and quality engineering techniquesto positively influence commercial and new product launches to ensure they aredeveloped and manufactured in accordance with regulatory, company, and customerrequirements. The Associate Director will review and evaluate scientific andtechnical data as it pertains to product and product testing and lead teams toidentify and solve complex problems.
This individual will:
- Actively represent DeviceDesign Quality function on commercial and product/core development teamssupporting quality issues related to medical devices or the device constituentof a combination product.
- Review and approve DesignControl and Device Risk Management documentation for regulatory filings,clinical supply, development and design transfers qualification. Evaluatedeficiencies and assess impact on compliance status.
- Contribute todeveloping/revising policy and procedures for Medical Device and Combination ProductQuality and/or supported areas.
- Remain informed of industrytrends as described in worldwide regulations and industry standards.
- Provide guidance to our manufacturing divisions and ourresearch labs device functions and other personnel to ensure end to end Qualityby Design, Six Sigma, Reliability, and Design Control principals areimplemented effectively.
- Participate in design reviews,CAPA reviews, and ad-hoc technical reviews of combination products.
- Be a hands-on participant inall stages of combination product development including but not limited tooversight of purchasing controls and supplier quality.
- Work with external partners todevelop products.
- Author retrospective designcontrol documentation that encompasses the life cycle and risk-based approachof development and sustaining activities.
- Reports to ensure that thetesting is sufficient to meet regulatory requirements and quality objectives.
- Provide input to design andmanufacturing documentation including material specifications, drawings,inspection procedures, and manufacturing procedures, to ensure that theresulting products can be adequately manufactured and tested.
- Facilitate translation of vaguecustomer needs into critical to quality and design inputs/output requirements,including but not limited to chemical, physical, and performancespecifications.
- A Bachelor’s degree in (Scienceor Engineering or associated fields) with at least 10 years of experience inMedical Device, Pharmaceutical and/or Combination Products OR
- A Master’s degree (Science orEngineering or associated fields) with at least 7 years of experience in MedicalDevice, Pharmaceutical and/or Combination Products OR
- A Ph.D. (Science or Engineeringor associated fields) with at least 3 years of experience in Medical Device,Pharmaceutical and/or Combination Products
Required Experience and Skills:
- In-depth knowledge of DesignControls, CAPA, Purchasing Controls and Risk analysis (ISO 14971)
- An understanding of MedicalDevice & Combination Product regulations (ISO 13485/11608, IEC 62304, 21CFRpart 820, 210/211 and 4).
- Must be able to workindependently within a cross functional framework
- A high degree of creativethinking, resourcefulness, and networking will be required to coordinateprojects or solve problems.
- Working knowledge of devicedevelopment and commercialization, product approval, and/or regulatoryinspection experience with the medical device constituent of a combinationproduct.
- High proficiency withstatistical tools (e.g., Minitab or Sigma XL)
- Strong technical writing skills
- Must be a technical expert,work independently, and have excellent interpersonal relationship skills withflexibility to adapt to fast pace environment with changing priorities.
Preferred Experience andSkills:
- Certified Lean Six Sigma GreenBelt or Black Belt and/or Certified Quality Engineer (CQE) strongly desired
- Strong understanding of GoodManufacturing Practices (GMP). Good Documentation Practices (QDP): and projectmanagement principals; is desirable.
- Lean Six Sigma Principles andtools such as: DOEs, Root cause analysis and/or Problem-solving methods aredesired
Job: Clinical, Non Clinical Quality Assurance
Job Title: EMEA-Netherlands-NH-Haarlem
Primary Location: EMEA-Belgium-Antwerp-Heist op den Berg, EMEA-Netherlands, EMEA-Belgium, EMEA-United Kingdom, EMEA-Netherlands-NB-Oss
Employee Status: Yes, 20 % of the Time