In this role, the Manufacturing Quality Engineer will be own on all activities at one of sub contractors supports the validation process to the contract manufacturing and provides 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:
- General
- 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.
- Documentation
- Responsible to write, review and approve pilot documents %28including reports%29.
- write and approve various department and production procedures and forms.
- Production
- Lead investigation processes for deviations and nonconformities in production and create analysis reports.
- Responsible to train 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 subcontractor to ensure manufacturing is held according to company procedures and GMP/GDP standards
- Responsible for stopping and renewing production with accordance to company requirements and with MQ manager approval.
- Manage production relates 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 includes change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to company guidance and protocols.
- Attend production pilot meetings as the MQ focal point.
Basic Qualifications:
- B.Sc. in Engineering or Science required
- 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
- 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
Preferred Knowledge, languages, Skills and Abilities:
- Graduate degree in Engineering
- 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
- Cerified auditor- a plus
Competencies/Authorities
- Stop/Approve production
- Approve product pilots documents .
- Risk documents, test methods, reports
