Title:  Quality Engineering Associate

Job Summary

In this role, the Manufacturing Quality Engineer will own on all activities at one of 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 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 product and production focal point for our sub-contractors and will be responsible for projects related to production and machines, including training, audits, stop and renewing the production.

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.
• Meet company and departmental goals in the continuous improvement of all products, services and processes. 
• 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 for training the sub-contractors according QA procedures and VoE.
• Supports special processes such as sorting or rework in production.
• Own on 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 which 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.

Essential Duties and Responsibilities:

• Production
  • Lead investigation processes for deviations and nonconformities in production and create analysis reports.
  • Responsible for training the sub-contractors according QA procedures and VoE.
  • Supports special processes such as sorting or rework in production.
  • Own on 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 which 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.

Delegation

• Manufacturing Quality Manager or qualified Manufacturing Quality 

• Team Lead Manufacturing Quality

Education

• B.Sc. in Engineering or Science required

Work Experience

• Minimum 3 years of experience in Medical Device Quality & Productionifecycle
• Relevant work history and/or experience may be considered in lieu of degree

• 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

Preferred Knowledge, Skills and Abilities

• 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
•  Experience with Medical Device / Pharma- Advantage
•  Validation Activities, Risk Management, Product Transfer  to production
• Working knowledge of quality systems such as ISO 13485, 21 CFR 820,SO 14971, MDSAP

Physical Requirements

Additional Requirements

• Previous experience with MasterControl, Share Point, Teamcenter- a plus
• 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 multi-task, work under time constraints, problem solve, and prioritize
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers
• Certified auditor- a plus
• Relevant work history and/or experience may be considered in lieu of degree