Job Description
BS in Engineering
2+ years of experience
Knowledge of DFMEA and PFMEA
Experience with Process V&V, IQ, OQ, PQ, CAPA, and TMV
Proficiency in SolidWorks
Familiarity with Minitab
Requirements:
BS in Engineering
2+ years of experience
Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971, and GMP
Knowledge of DFMEA and PFMEA
Familiarity with process mapping and critical to quality reviews
Preferred Skills:
Experience working with statistical analysis tools including Minitab, DOE, process capability, measurement system, and confidence interval analysis
Proficiency in PTC Creo or SolidWorks
Understanding of CAPA, root cause investigations, and quality tools such as DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram, and Pareto Charts
Experience or knowledge of engineering drawings and GD&T
Responsibilities:
Conduct Process V&V, IQ, OQ, PQ, and TMV activities
Utilize DFMEA and PFMEA methodologies
Develop and maintain design and manufacturing documentation
Collaborate with teams on CAPA and root cause investigations
Ensure compliance with relevant regulations and standards, including FDA and ISO requirements
Pay Details: $40.00 to $50.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Company Description
Specializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.