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Quality Manager, Engineering & Manufacturing Job in Ra'anana Recruiting by West Pharmaceutical Services

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Quality Manager, Engineering & Manufacturing

🔖 Full Time

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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.

Essential Duties and Responsibilities:

Provide guidance on Ops, technical and engineering processes/documentation to ensure compliance to procedures, relevant regulations and standards.

Lead Sr. Quality Eng., team leaders, Quality Engineers and Quality personnel in the day-to-day activities- performance and tasks handling, set priorities, training, and objectives according to the organizational goals.

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.

Lead the Quality involvement in design and maintenance of product and production process and hazard analysis in accordance with West policies and procedures.

Provide Quality oversight and guidance to design transfer and process qualification and validation activities to other Sr. QEs.

Provide quality oversight, approval and guidance for qualification documentation and reports

Provide direction and guidance with problem solving techniques for technical and process reviews in cases of escalations.

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.

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.

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) .

Drive and , lead projects related to CoPQ, Right First Time, etc.

Work cross-functionally with other team managers and project teams leaders to provide QA guidance and ensure success of projects.

Provide guidance with customer meetings and support escalations related to customer issues to QA aspects of, sterilization, production nonconformities and process validation.

Review and approve QMS procedures, waivers, NCMR, failure investigations, product specifications, ECOs/DCOs, risk analysis and software validations.

Support QMS activities including CAPA, Failure Investigation, OOS, Non-Conformance assessment, internal/external audits, or Other duties as assigned

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

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 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

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:

Courses on topics related to quality system/regulatory requirements in the medical device industry

English- high level in both verbal and written

Certified auditor- advantage

Experience with ISO 60601, ISO 62366, ISO 11607- a plus

Previous experience with Master Control, SAP, Share Point, Teamcenter

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

Lead Sr. QEs and QEs responsible for review and approval of technical documentation

Sets priorities for the applicable Sr. Quality Eng. and QA personnel, coach and provide guidance

Address technical issues as the QA rep.

Sterilization SME

Must be able to multi-task, work under time constraints, problem solve, and prioritize

Ability to make independent and sound judgments

Observe and interpret situations, analyze and provide guidance in different teams’ problems solving

NCMR approval & closure

Raw material approval

Calibration approval (including deviations)

Approve Manufacturing Quality related documentation- Special Instructions, Rework, Deviations, Stop/Renew production

Perform training to CM

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

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Are You Looking for a Quality Manager, Engineering & Manufacturing job in Ra'anana?

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The work culture at West Pharmaceutical Services must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs West Pharmaceutical Services and also by visiting their official website through Google.
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