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Design QE Manager

Requisition ID:  35414
Date:  Jul 9, 2021
Location: 

Scottsdale, Arizona, US

Department:  Quality

 

 

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 Quality Engineer Manager is accountable for supporting and leading a team to support new product development and provide quality oversight to the R&D / Innovation and Technology (I&T) organization 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. Support Supplier nonconformances, customer complaint data acquisition, root cause analysis, corrective action and complaint handling as required.  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
  • Directs and manages quality staff to assure knowledge and execution of Quality System
  • Recognizes development opportunities and talent of team members then work to grow expertise
  • 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 provide oversight to multiple product development projects throughout the organization, including involvement from multiple sites.
  • Utilize PMI strategies and techniques to manage scope, time, and budget
  • Maintain clear communication paths with stakeholders
  • Conduct routine resource reviews with project teams and management
  • Manage and maintain an effective Quality Assurance program and operating procedures in alignment with enterprise procedures and applicable standards
  • 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
  • Drive continuous quality improvement and product monitoring projects
  • Provide Quality oversight of qualification/validation/design controls activities
  • Work cross-functionally with individuals and project or extended teams to ensure success of projects
  • Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
  • 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.
  • Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
  • Work with management and technical staff in performing root cause failure analysis and support the implementation of corrective and preventive actions to eliminate recurrence.
  • Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
  • Review and approve Supplier product / process deviations or rework documentation.
  • Review and approve internal protocols, reports, product / process deviations or other documentation.
  • Provide quality reports and review trending on assigned areas of responsibility.
  • Review and approval of qualification documentation and reports
  • Assist and provide guidance on any nonconformance that may occur
  • Attend program meetings as required as part of extended program teams
  • Liaison with company and customers on Quality matters
  • Drive compliance to global harmonization initiatives
  • Work cross-functionally with individuals and project or extended teams to ensure success of projects
  • Fill in for the I&T 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 7-10 years of experience in regulated Quality Assurance / Quality Control
  • Education or Equivalent Experience: Bachelor's in Science, Operations, or Business
  • Relevant degree, work history and/or experience may be considered in lieu of degree and/or years’ experience.
  • 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 policy at all times

 

Preferred Knowledge, Skills and Abilities:

  • Master’s degree in engineering
  • Strong project management skills
  • ASQ certification (CQE or CQA)
  • Green or Black Belt certification
  • Chemistry or Engineering Degree
  • Graduate degree
  • Prior Master Control experience preferred

 

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
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Maintain high attention to detail, accuracy, and overall quality of work
  • Effectively communicate and interface with various levels internally and with customers

 

 

 

 

 

 

 

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 kimberley.eby@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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