Quality Engineering Manager 69380
Quality Engineering Manager 69380
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Salary Not Disclosed
1 Vacancy
Job Description
At West were a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of lifesaving and lifeenhancing injectable medicines to millions of patients daily Wests indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future
Theres no better place to join an inclusive community of professionals with opportunities for lifelong learning growth and development. Supported by benefit programs we empower the physical mental emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
Essential Duties and Responsibilities
- Exhibit a strong quality first mentality and ensure that product and process quality are held to the highest standard.
- Provide Quality oversight and direction for Quality Engineers.
- Provide direct supervision resolves personnel issues conducts performance evaluations and performs supervisory discipline as necessary.
- Recommend evaluate and implement process changes that are designed to continually improve the quality management system.
- Provide quality oversight author review and/or approve site documentation (validation change control SOPs WKIs etc).
- Lead and manage QMS activities including CAPA Failure Investigation NonConformance assessment audit findings issue reviews etc. Provide leadership and direct input on any nonconformance deviation or excursion that may occur and drive to closure.
- Direct involvement with FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented. May act as lead for ISO and customer audits.
- Interface with customers for quality issues technical information specification agreements audits etc.
- Recruit train develop and lead staff to accomplish personal and organizational goals adhere to policies/procedures and establish/maintain a culture of quality.
Additional Responsibilities
Education
- Bachelors Degree in Engineering or Science required and
- Chemistry or Engineering Degree preferred and
- Graduate degree preferred
Work Experience
- Minimum 8 years Minimum 810 years of experience required and
- Relevant work history and/or experience may be considered in lieu of degree and/or years of experience required and
- Previous experience with MasterControl SAP Share Point Teamcenter preferred and
- Experience with ISO 13485 and 21CFR Part 820 210 and/or 211 preferred
Preferred Knowledge Skills and Abilities
- Preferred previous experience with Master Control SAP SharePoint Teamcenter
- Experience using Six Sigma and SPC tools and techniques
- Ability to use Excel Word programs
- Must be able to operate and maintain office equipment (i.e. copy machines multimedia etc..
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the companys safety policy at all times
- Able to comply with the companys quality policy at all times.
License and Certifications
- Engineering GeneralASQ Certified Quality Engineer (CQE or CQA) Upon Hire preferred and
- ManufacturingSix Sigma Green Belt Certification Upon Hire preferred or
- ManufacturingLean Six Sigma Black Belt Upon Hire preferred
Travel Requirements
Physical Requirements
Additional 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 multitask work under time constraints problem solve and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations analyze and solve problems
- Effectively communicate and interface with various levels internally and with customers
#LIKR1
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe treated fairly valued and respected. We do not discriminate on the basis of race religion color national origin gender sex gender identity sexual orientation age marital status veteran status disability status or other applicable legally protected characteristics. Where permitted by law employment with West Pharmaceutical Services Inc. or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of postoffer background screening and/or drug screening.
Required Experience:
Manager
Employment Type
Full Time
