Our industry leading medical device design and manufacturing client has an immediate opening for an experienced Quality Engineer.
Essential Job Functions:
- Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner
- Meets commitments on time with accuracy and attention to detail
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Provide interpretive assistance, to all departments, regarding these documents
- Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified
- Design, execute, and document gage R&R studies
- Support training on Manufacturing and Quality System documents
- Quality Representative for Material Review Board (NMR)
- Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
- Develop validation and/or verification protocols; execute validations/verifications and report on the conclusions to support new product development or process improvements
- Release documents via the change control process as necessary. Train others where required
- Support, investigate, determine root cause and respond to customer complaints and customer issued SCARs
- Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols)
- Prepare quality related deliverables in a timely manner
- Prepare and execute Engineering studies as needed
- Participate in CAPA root cause investigation and actions implementation.
- Implement ongoing quality improvement processes working with cross functional teams
- Acts as a consultant for areas related to his/her expertise.
- Performs other related duties as assigned by management
Ideal Candidate Will Possess The Following:
- Must have three (3) years experience with a focus on equipment validation, calibration, and maintenance
- A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge
- Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required
- Basic knowledge of ISO 13485:2016 and FDA QSR
- Strong root-cause investigator and problem solver within a manufacturing environment.
- Mechanical aptitude with manufacturing experience
- Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos
- Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form
- Well versed in data management and graphical presentation of data
- Ability to generate reports using data analysis, SPC analysis/tools, and effectively communicate findings/proposals to various users in the organization
Job Type: 3 to 6 months temp
Salary: $25 - $29 / HR