Quality Engineer at Jobot
Bridgeport, CT 06610
About the Job
Quality Engineer- Medical Device
This Jobot Job is hosted by: Ana Javalera
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $90,000 - $100,000 per hour
A bit about us:
Based in Bridgeport, CT with 6 offices across the region we are a TOP ranked Medical Device Manufacturer! Our core values are centered around our people and our clients. We believe that putting your employees first is not only the right thing to do, but it also gives us the competitive edge to ensure our clients have an excellent experience! Over the years our reputation for providing our people with the very best has caught the eye of some reputable clients who have chosen to use us as their primary firm!
Why join us?
We are a global medical manufacturer that produces medical devices and components for everything from implants and surgical instrumentation to single-use disposable devices and assemblies. With over a dozen locations worldwide, we offer extensive opportunities for you to grow and advance your career.
We’re committed to creating an exceptional work environment for all our employees. That includes strong work-life balance, supportive teams, and opportunities for advancement. As soon as you start working with us, you’ll have access to:
Health benefits starting from day one
Retirement plan with company match
Sign on bonus
Off-shift premiums
Relocation benefits
Job Details
Duties and Responsibilities
Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing.
Ensuring cell processes are correctly base-lined & controlled.
Completes the implementation and performance of gage R&R, process capability studies, design of experiments and summaries as required to improve quality and required deliverables to customers.
Ensuring processes released with use of SPC, where applicable, and/or promote use of SPC.
Provides SPC & monitoring of SPC.
Investigates deviations, OOS, complaints, returns, recalls and field alerts.
Supports the Material Review Board )MRB) for internal non-conformance and customer returns.
Lead a verify effectiveness of corrective and preventative actions (CAPAs).
Supervise and train personnel in the inspection of raw materials and in-process and finished goods.
Ensure compliance with all production procedures.
Ensure compliance with all FDA, customer, and Paragon Medical reporting requirements (Device Master Records and Device History Records)
Create, implement oversee and improve quality and quality systems per ISO 13485, FDA and customer requirements.
Support Cell Leaders in ensuring CNC machinists are knowledgeable and competent in these and care of equipment and related requirements.
Create and support ECN's and SCR's (product).
Support audits of corporate quality systems, demonstrating compliance via objective evidence.
Meet the visual acuity and vision screening test requirements (shades of color, color blindness, eye chart).
Education
Bachelors in Engineering or related field is preferred.
Experience
0 - 3 years with tight tolerance measurement systems in machining applications, blueprint reading, and GD&T.
Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulations.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Ana Javalera
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $90,000 - $100,000 per hour
A bit about us:
Based in Bridgeport, CT with 6 offices across the region we are a TOP ranked Medical Device Manufacturer! Our core values are centered around our people and our clients. We believe that putting your employees first is not only the right thing to do, but it also gives us the competitive edge to ensure our clients have an excellent experience! Over the years our reputation for providing our people with the very best has caught the eye of some reputable clients who have chosen to use us as their primary firm!
Why join us?
We are a global medical manufacturer that produces medical devices and components for everything from implants and surgical instrumentation to single-use disposable devices and assemblies. With over a dozen locations worldwide, we offer extensive opportunities for you to grow and advance your career.
We’re committed to creating an exceptional work environment for all our employees. That includes strong work-life balance, supportive teams, and opportunities for advancement. As soon as you start working with us, you’ll have access to:
Health benefits starting from day one
Retirement plan with company match
Sign on bonus
Off-shift premiums
Relocation benefits
Job Details
Duties and Responsibilities
Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing.
Ensuring cell processes are correctly base-lined & controlled.
Completes the implementation and performance of gage R&R, process capability studies, design of experiments and summaries as required to improve quality and required deliverables to customers.
Ensuring processes released with use of SPC, where applicable, and/or promote use of SPC.
Provides SPC & monitoring of SPC.
Investigates deviations, OOS, complaints, returns, recalls and field alerts.
Supports the Material Review Board )MRB) for internal non-conformance and customer returns.
Lead a verify effectiveness of corrective and preventative actions (CAPAs).
Supervise and train personnel in the inspection of raw materials and in-process and finished goods.
Ensure compliance with all production procedures.
Ensure compliance with all FDA, customer, and Paragon Medical reporting requirements (Device Master Records and Device History Records)
Create, implement oversee and improve quality and quality systems per ISO 13485, FDA and customer requirements.
Support Cell Leaders in ensuring CNC machinists are knowledgeable and competent in these and care of equipment and related requirements.
Create and support ECN's and SCR's (product).
Support audits of corporate quality systems, demonstrating compliance via objective evidence.
Meet the visual acuity and vision screening test requirements (shades of color, color blindness, eye chart).
Education
Bachelors in Engineering or related field is preferred.
Experience
0 - 3 years with tight tolerance measurement systems in machining applications, blueprint reading, and GD&T.
Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulations.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
90,000 - 100,000 /year