43 applicants
Enercon Technologies · 3 days ago
Quality Engineer
Gray, ME
Full-time
Onsite
Mid Level
4+ years exp
Wonder how qualified you are to the job?
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Hiring Manager
Deborah Barriss
Insider Connection @Enercon Technologies
Responsibilities
Lead CAPA activities and non-conformance investigations
Develop and lead implementation of continuous improvement plans
Lead supply chain quality management activities including audits and vendor CAPA’s
Manage the incoming inspection department
Participate in activities to ensure manufacturing processes are properly validated and in compliance with company, ISO, and regulatory requirements
Participate in the development of Failure Mode and Effects Analysis (FMEA)
Lead internal quality system audits
Lead audits from regulatory and safety agencies, customers, and registrars
Participate in design reviews as needed
Qualification
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Required
Bachelor’s degree in a related engineering discipline
4+ years related experience in the development and maintenance of quality management system and documentation control processes and procedures
Strong working knowledge of FDA medical device regulations, and ISO 13485 requirements in quality management systems and documentation control
Preferred
Related experience in an FDA regulated medical device company is strongly desired
Experience with printed circuit board assembly and test highly desirable
Experience implementing lean manufacturing and/or six sigma desirable
Advanced word processing (Microsoft Word), database (Access) and spreadsheet (Excel) skills
Company
Enercon Technologies
Enercon Technologies is an electronics manufacturing company that provides product development, testing, marketing, and design services.
201-500 employees
H1B Sponsorship
Enercon Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (1)
2021 (5)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Essex Woodlands Healthcare Partners
2023-05-18Series Unknown· Undisclosed
Recent News
2023-05-19
Company data provided by crunchbase
