Title:  Manufacturing Quality Engineer

Job Summary

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.

Education

• Bachelor's Degree in Engineering or science related- required
• Relevant work history and/or experience may be considered in lieu of degree

Work Experience

• Minimum 3 years of experience in a quality engineering role in a regulated industry, pharmaceutical, or medical device manufacturer- required 

Preferred Knowledge, Skills and Abilities

• Experience with production processes and process controls
• Experience with sub contractors interface and meeting customer expectations
• Experience with Medical Device, Validation Activities, Risk Management, Product Transfer  to production
• Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
• 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

Additional Requirements

• Minimum 3 years of experience in Medical Device Quality & Production lifecycle
• Experience with production processes and process controls
• Experience with sub contractors interface and meeting customer expectations
• Experience with Medical Device, Validation Activities, Risk Management, Product Transfer  to production
• Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
• 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