Quality Design Engineer

Company Info
Phoenix, AZ, United States

Phone: 6104258007
Web Site: www.westpharma.com

Company Profile


Quality Design Engineer


Phoenix, AZ 

Job ID:


Job 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:

In this role, you will assure compliance of the design center processes and product to established standards, specifications, and procedures to ensure the quality system is implemented and its integrity maintained.  The Design Quality Engineer Manager is accountable for supporting and leading a team to support multiple concurrent new product development projects and to provide quality oversight to the R&D and Design Quality teams while working within a multi-functional team environment for medical devices.  The incumbent will lead a team of quality team members, including quality engineers, to handle projects and tasks from product inception through design transfer & validation and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.


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.  Develop systems or programs that support continual improvement of product, process or QMS. Oversee manufacturing activities while projects remain in development.  Also perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its suppliers.


Essential Duties and Responsibilities:

  • Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
  • Provide guidance, direction, and mentorship to direct reports regarding all development activities outlined within this job description
  • Lead and provide oversight to multiple product development projects throughout the organization, including involvement from multiple sites.
  • Work independently and lead direct reports to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
  • Lead and support manufacturing operations for products which are still in development including ensuring product is released in a timely manner while maintaining compliance to regulatory and West QMS requirements
  • Prepare, review, approve, and provide guidance on product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, product transfer to operations, etc.) in relation to medical devices
  • Prepare, review, approve, and provide guidance on manufacturing documentation for products which are still in development (eg., pFMEAs, test method qualifications, equipment qualifications, design transfer activities, BPR approval, product certifications, product release, etc)
  • Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
  • Directs and manages quality staff to assure knowledge and execution of Quality System
  • Review and approve Supplier product / process deviations or rework documentation.
  • Review and approve internal protocols, reports, product / process deviations or other documentation.
  • Provide Quality oversight of qualification/validation/design controls activities
  • Author and review product development QMS procedures and work instructions
  • Work cross-functionally with individuals and project or extended teams to ensure success of projects
  • Supports technical and design review activities as a Quality representative SME
  • Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
  • Work with management and technical staff in performing root cause failure analysis and support the implementation of corrective and preventive actions to eliminate recurrence.
  • Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
  • Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
  • Recognizes development opportunities and talent of team members then work to grow expertise
  • Conduct routine resource reviews with project teams and management
  • Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports
  • Establish procedures & methods to comply with applicable ISO requirements and customer expectations
  • Provide quality reports and review trending on assigned areas of responsibility.
  • Assist, review, provide guidance on, and approve nonconformances which may occur
  • Attend program meetings as required as part of extended program teams
  • Establish routine communication strategies for project tracking and prioritization
  • Drive continuous quality improvement and product monitoring projects
  • Drive solutions to ensure customer related problems/issues are communicated
  • Works with minimal supervision to evaluate gaps and lead projects to close them
  • Liaison with company and customers on Quality matters
  • Maintain clear communication paths with stakeholders
  • Drive compliance to global harmonization initiatives
  • Fill in for the Senior Director as requested or required
  • Support the development and growth of direct reports
  • Adhere to all company policies
  • Follow all safety rules and safety procedures
  • Must observe all good housekeeping practices
  • Other duties as assigned


Basic Qualifications: 

  • Minimum 8-10 years of experience in regulated Quality Assurance / Quality Engineering
  • Education or Equivalent Experience: Bachelor's in Science or applicable engineering field
  • Relevant degree, work history and/or experience may be considered in lieu of degree and/or years’ experience.
  • Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
  • Must have an in-depth knowledge of validations in a Medical Device environment
  • 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, and 21 CFR 820)
  • Excellent written and oral communication skills
  • Excellent critical reading and writing skills
  • Must have effective problem solving and interpersonal skills
  • Ability to work independently, multi-task and thrive in fast-paced environment
  • Problem solving including root cause failure analysis methods
  • Planning/organizational skills
  • Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety & quality policy at all times


Preferred Knowledge, Skills and Abilities:

  • Graduate degree / Master’s degree in engineering
  • Chemistry or Engineering Degree
  • 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 a plus


Travel Requirements:

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