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Title:  Director, Design Quality, Quality Engineering

Requisition ID:  59423
Date:  Nov 22, 2022
Location: 

Remote, Remote, US

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

The Director of Design Quality Engineering serves as a key strategic partner to successfully drive proprietary product development and sustainment activities.  The role is responsible for maintaining compliant and state-of-the-art design control processes and leading a team who provide quality engineering oversight to multiple concurrent platform programs including medical devices, combination products, and/or containment. 

This global role will ensure assigned product platform development teams have sufficient Design Quality Engineering support and will constantly monitor and adapt to changing needs according to risk and business needs.  This role partners with R&D and Regulatory to ensure development programs are compliant with regulatory and business requirements throughout the complete development lifecycle including transfer to manufacturing and sustainment.  This role is also responsible for Design Quality oversight of documentation submitted to regulatory authorities in support of commercial launch. This role will partner with R&D and Regulatory to drive strategies to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies. 

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. Participate in steering committees and project teams which originate from supplier, customer and manufacturing facilities.  In partnership with other Global Design Quality leaders and Global R&D leaders, this role will drive global harmonization of the overall enterprise QMS and is accountable for driving alignment of the product development life cycle process across the West sites. 

 

Essential Duties and Responsibilities:

  • Develop and manage a high performing global team of West Design Quality staff responsible for ensuring:
    • Execution of defined business goals & objectives
    • Proprietary product designs comply with applicable global quality and regulatory requirements
  • Partner with other Global Design Quality and Global R&D leaders to deploy strategic platform product development approaches to product development.  Provide leadership and oversight to multiple concurrent complex product development programs throughout the organization and multiple sites.
  • Oversee and provide direction to cross-functional teams on product development DHF documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation.
  • Establish a state-of-the-art Design for Reliability excellence program and partner with Global R&D Leaders to implement the program enterprise-wide for all proprietary products.
  • Establish a state-of-the-art Design for Manufacturing excellence program and partner with Global R&D, Operations, and Operations Quality Leaders to implement the program enterprise-wide for all proprietary products.
  • Provide support in the creation of, resourcing for, and enforcement of development agreements for West proprietary products in collaboration with commercial, product management, R&D, regulatory, and operations.
  • Understands customers’ requirements and needs during a development agreement to define a standard method for establishing, implementing, and enforcing customer agreements.
  • Work closely with Global and site level Operations and Operations Quality regarding the interpretation and implementation of the QMS and ensure smooth technical transfers into Operations.
  • Ensure the applicable development phase requirements are sufficiently fulfilled and documented within the DHF before allowing the project to proceed within the development process.  Escalate and prevent the progression of product development, including release of clinical product, if warranted.
  • Lead and support manufacturing operations for products which are still in development including ensuring product is released according to schedule while maintaining compliance to regulatory and West QMS requirements
  • Ensure cross-functional teams collaborate across the enterprise.  Communicate key messages, goals, and objectives to team members to drive alignment and a high-performance culture.
  • Oversee customer management between internal and customer Design Quality teams to ensure strong partnerships are established and customer commitments are satisfied.
  • Partner with other Global Design Quality leaders and Global Quality Systems leadership in developing and implementing lean QMS processes at the enterprise level.  Lead and drive compliance to global harmonization initiatives and objectives.
  • Direct a harmonized design control program globally within the enterprise with the support of Design Quality leadership.  Proactively identify potential gaps and direct teams to resolve them. Lead continuous improvement initiatives to ‘challenge’ quality systems processes with respect to compliance / value add.
  • Identify, develop, mentor, and lead Design QA talent to ensure the highest standard of Quality support is provided to R&D design & development teams. Collaborate with leadership to identify succession plans.
  • Forecast and ensure the appropriate level of Design QA staffing is maintained to support multiple concurrent new device and containment development projects. 
  • Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives.  Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
  • Oversee QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc.  Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
  • Remain aware of developments in the quality field by reading current technical literature and attending technical meetings and/or industry conferences.
  • Fill in for the Senior Director as requested or required
  • Drive continuous quality improvement projects
  • Must observe all good housekeeping practices
  • Other duties as assigned

 

Basic Qualifications: 

  • Minimum 10 years of experience in regulated Medical Device Quality
  • Education or Equivalent Experience: Bachelor's in Science or applicable engineering field
  • Relevant work history and/or experience may be considered in lieu of degree and/or years of experience
  • Have previously led and managed the performance of multi-functional team(s) in Quality
  • Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
  • Have experience in overseeing the design and development of medical devices in conformance with US FDA, CE Marking requirements, and/or similar regulatory approval routes
  • Experience with customer interface and meeting customer expectations
  • Experience using Six Sigma & SPC tools and techniques
  • Experience with medical device regulations (ISO 13485, ISO 14971, 21 CFR 820, EU GMP, and EU MDR)
  • Strong project management skills
  • Excellent written, critical reading, and oral communication skills
  • Must have effective problem solving and interpersonal skills
  • Strong problem-solving skills including root cause failure analysis methods
  • Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams
  • Be aware of all relevant SOPs as per Company policy as they relate to this role
  • Able to comply with the company’s safety policy at all times

 

Preferred Knowledge, Skills and Abilities:

  • Graduate degree / Master’s degree in engineering
  • Strong project management skills
  • ASQ certification (CQE or CQA)
  • Green or Black Belt certification
  • Previous experience with MasterControl, SAP, Share Point, Teamcenter
  • Experience with ISO 60601, ISO 62366, ISO 11607, ISO 11608 a plus

 

Travel Requirements:

  • Must be able to travel up to 20% of the time

 

Physical & Mental Requirements:

  • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
  • Must maintain the ability to work well with others in a variety of situations
  • Maintain high attention to detail, accuracy, and overall quality of work
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Observe and interpret situations, analyze and solve problems
  • Effectively communicate and interface with various levels internally and with customers

 

Competencies/Authorities

  • Non-US only where required for certain levels

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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