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Title:  Quality Engineering Manager

Requisition ID:  56229
Date:  Nov 11, 2022
Location: 

Scottsdale, Arizona, 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.

 

POSITION SUMMARY: Responsible for Managing the Quality Engineers and other technical support functions (including the Metrology Lab, and Biologics lab).  Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational competence within area of responsibility. Will set strategic direction of these areas and define priorities for work to be performed based on business needs; as well as ensuring that these areas are partnering with operations to meet production needs.  Will understand needs of customers and communicate with customers as necessary. Ensure the systems and products comply with applicable government regulations; as well as internal processes and procedures. Will work to continuously reduce risk and improve compliance, and productivity. 

ACCOUNTABILITIES:

  1. Accountable for the activities of the technical Quality Engineering functions at the Scottsdale Operations Center.
  2. Understand the needs of Operations and the business overall to set priorities for the Quality Engineering group.
  3. Evaluate, design, implement and improve production and process control strategy to achieve quality management and plant objectives. Create strategies to control costs, reduce risks and improve productivity.
  4. Review and approve documents such as laboratory investigations, work instructions, SOP’s, device master record, qualifications and validation protocols and results, etc., as assigned.
  5. Provide effective quality engineering leadership in teamwork development, effective communication, and quick responses to customer needs
  6. Build organization capability for quality engineering in the selection and mentoring of professionals.
  7. Build a strong interactive, working, and strategic relationship with design quality engineering manufacturing, R&D, corporate quality management and other staff.
  8. Oversee the vendor qualification and certification programs in collaboration with supply management and the corporate supplier quality group. Accountable for supplier non-conformances and improvement projects.
  9. Assist and participate in audits.
  10. Keep current with new technologies and cGMP regulations.
  11. Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, i.e.,: Lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving. Conduct training and re-certification as appropriate for quality and other personnel in relation to improvements of the quality system.
  12. Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, etc.).
  13. Ensure that functions are properly resourced to meet goals and objectives of the business
  14. Assure that direct reports have been adequately trained for their role.
  15. Recruit, train, develop, and lead staff to accomplish individual and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.
  16. Assure that the Quality System is compliant with applicable Regulatory and Industry standards.
  17. Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.
  18. Generate, review, or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply, and quality agreement), verification of compliance, or for filings with regulatory bodies.
  19. Perform other tasks as assigned Assist in the execution Quality strategic plans and policies for Scottsdale site.
  20. Decisions are guided by policies, procedures, and business plan; receives guidance from the senior manager.

The job descriptions reflect the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.

BASIC QUALIFICATIONS:

Education: Bachelor’s degree in engineering or science related field

Experience:   8+ years of experience in a Medical Device/GMP industry; with 2-3 years of supervisory experience. Experience working with validations, pFMEA, Risk Management, Root Cause Methodology, CAPA, MSA

Direct/Indirect Reports: Quality Engineers

PREFERRED KNOWLEDGE, SKILLS, and ABILITIES

  • Master’s degree preferred with an emphasis in Engineering, Science, or Business. 
  • Six Sigma certified Black Belt preferred
  • Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
  • Ability to work effectively with teams and manage multiple tasks in order to meet tight deadlines
  • Effective functional and technical knowledge. Experience with effective use of Quality Tools (MSA, Capability, pFMEA, validations) as well as statistics and sampling plans
  • Demonstrated people skills specific to team building, problem solving and conflict resolution.
  • Knowledge of GMP requirements.
  • Project management experience
  • Excellent presentation, writing, verbal, computer, interpersonal and communication skills.
  • Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
  • Manages competing demands, makes timely and sound decisions, even under conditions of risk.
  • Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding.

PHYSICAL & TRAVEL REQUIREMENTS: Minimum Travel

West Pharmaceutical Services is an Equal Opportunity Employer

 

 

 

 

 

 

 

 

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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