Title:  Quality Manager, Engineering & Manufacturing

At West, we’re 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 life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

There’s 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:

In this role, the Engineering & Manufacturing Quality Manager leads Sr. Quality Engineers, Quality Engineers and personnel who provide quality oversight the Ops Quality platform, such as Engineering, process validations, production lines development and qualifications, material acceptance, Quality presence at production and manufacturing failure investigations while working within a multi-functional team environment for medical devices. The Quality Engineering & Manufacturing Manager leads personnel who review and approve projects, tasks and nonconformities, from product realization, design transfer, production process establishment and changes, production controls and manufacturing supervision and plays an active role to ensure that production processes meet all applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements. The Quality Engineering & Manufacturing Manager will be a strong advocate for product and process quality at all stages. Additionally, this role leads Sr. Engineers responsible for the medical devices’ sterilization methods establishment, validation, control, and maintenance activities. Furthermore, the Quality Engineering & Manufacturing Manager leads personnel who are responsible for the production documentation (DHR) and finished product release to market by monitoring the manufacturing and release processes, including a verification that the sterilization and Endotoxin levels meet the applicable requirements.

The Quality Engineering & Manufacturing Manager will support continuance improvement of product, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (MasterControl,  SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.

Essential Duties and Responsibilities:

1. Exhibit a strong “quality first” mentality and ensure that product, process and QMS are held to the highest standard.
2. Provide guidance on Ops, technical and engineering processes/documentation to ensure compliance to procedures, relevant regulations and standards.
3. Lead Sr. Quality Eng., team leaders, Quality Engineers and Quality personnel in the day-to-day activities- supervise performance and tasks handling, set priorities, training, and objectives according to the organizational goals.
4. Lead Sr. Quality Engineers and QEs who review and approve technical/ Engineering documentation (DMR, IQ, OQ, PQ, product specifications, process validation and qualification activities, FMEA risk documents, test methods, protocols, reports, OOSs, design transfer, etc.) in relation to medical devices.
5. Lead the Quality involvement in design and maintenance of product and production process and hazard analysis in accordance with West policies and procedures.
6. Provide Quality oversight and guidance to design transfer and process qualification and validation activities to other Sr. QEs.
7. Provide quality oversight, approval and guidance for qualification documentation and reports
8. Provide direction and guidance with problem solving techniques for technical and process reviews in cases of escalations.
9. Lead the site’s device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the West Global Sterilization Council and provide support to other West CM and Medical device sites with Sterilization issues. Be key focal point with the West IL sterilization service providers related to sterilization matters.
10. Lead Sr. Quality Engineer who is responsible for Manufacturing Quality Engineers presence at the Contract Manufacturing, audit processes and production controls, onsite GMP inspections, failure investigations (NCMR), verify compliance with West’s production, inspection, and maintenance procedures.
11. Lead Sr. Quality Supervisors who are responsible for Quality personnel oversight over production controls, calibration, raw material acceptance, auditing production related documentation, DHR, batch records, labelling release, finished products release to market (including review and approval of sterilization and Endotoxin testing documentation) .
12. Drive and support continuous quality improvement projects, lead projects related to CoPQ, Right First Time, etc.
13. Work cross-functionally with other team managers and project teams leaders to provide QA guidance and ensure success of projects.
14. Provide guidance with customer meetings and support escalations related to customer issues to QA aspects of, sterilization, production nonconformities and process validation.

15. Review and approve QMS procedures, waivers, NCMR, failure investigations, product specifications, ECOs/DCOs, risk analysis and software validations.
16. Support QMS activities including CAPA, Failure Investigation, OOS, Non-Conformance assessment, internal/external audits, or Other duties as assigned
17. Adhere to all company policies.

Basic Qualifications: 

• B.Sc. in Engineering or Science required
• Minimum 10 years working in Medical Device / Pharma industry- in Quality roles
• Minimum 8 years working in the areas of design controls/process validation
• Experience with customer interface and meeting customer expectations
• Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
• Must have an in-depth knowledge of product verification and process validations in a Medical Device environment
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
• Knowledge in applicable sterilization standards and methods, such as ISO 11137 and ISO 11135
• 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
• Proficient in statistical software, 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, languages, Skills and Abilities:

1. Courses on topics related to quality system/regulatory requirements in the medical device industry
2. English- high level in both verbal and written
3. Certified auditor- advantage   
4. Experience with ISO 60601, ISO 62366, ISO 11607- a plus
5. Previous experience with Master Control, SAP, Share Point, Teamcenter
6. Manage at least 4 Sr. QEs/team leaders
7. Relevant work history and/or experience may be considered in lieu of degree

Travel Requirements:

• Must be able to travel up to ___5___ % of the time

Competencies/Authorities

1. Lead Sr. QEs and QEs responsible for review and approval of technical documentation
2. Sets priorities for the applicable Sr. Quality Eng. and QA personnel, coach and provide guidance
3. Address technical issues as the QA rep.
4. Sterilization SME
5. Adaptable to changes in the work environment, manage Sr. QEs and additional QA personnel in competing demands and deal with frequent change, delays or unexpected events.
6. Must be able to multi-task, work under time constraints, problem solve, and prioritize
7. Ability to make independent and sound judgments
8. Observe and interpret situations, analyze and provide guidance in different teams’ problems solving
9. NCMR approval & closure
10. Raw material approval
11. Calibration approval (including deviations)
12. Approve Manufacturing Quality related documentation- Special Instructions, Rework, Deviations, Stop/Renew production
13. Perform training to CM
14. Effectively communicate and interface with various levels internally and lead the Quality personnel for success.

Delegation/s (Title):

Applicable qualified Quality Engineers and personnel/ QA Director

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.