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A fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Production Quality Engineer to join the QA product team.
Job Description:
Serve as owner of the NCMR process: manage the end-to-end handling of non-conforming materials, products, and processes, including initiation, investigation and corrective/preventive actions in accordance with company procedures and regulatory requirements.
Monitor NCMR process including quality KPIs
Support for non-conformity investigations and assign effective corrective actions for NCMRs and ensure timely closure and documentation.
Perform / review Root Cause Analysis as part of NCMR process and assign relevant corrective actions.
Act as QA representative for Manufacturing Quality process
Conduct quality assurance activities such as data analysis and statistical evaluations, SOP review and approvals, audit preparation
Direct Manager: Manufacturing Quality Manager

In this fully onsite role, the Manufacturing Quality Engineer will own all qualiy activities at one of the manufacturing sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to the production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. Additionally, this role will identify and implement improvements to the production processes. The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that product and quality are held to the highest standard.
Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects.
Responsible to write, review and approve pilot documents (including reports).
Write and approve various department and production procedures and forms.
Lead investigation processes for deviations and nonconformities in production and create analysis reports.
Responsible to train the sub-contractors according to QA procedures and VoE.
Support special processes such as sorting or rework in production.
Own all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
Manage production related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
Provide Quality oversight of validation activities and processes.
Lead pilot processes that include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
Attend production pilot meetings as the MQ focal point.