Quality Engineer - FULL TIME

Purpose

  • To implement the company’s Quality Policy and ensure that the requirements of ISO 13485-2016 and other applicable industry standards are maintained.
  • To ensure that all customer requirements are met with regard to communication, quality and delivery for validation documentation.
  • To develop and maintain good working relationships with all of the customers of Forum Plastics LLC.
  • To work with the management of Forum Plastics LLC to seek new customers and supportive vendors that will aid our quest to grow our company.
  • To provide support for all Quality activities related to new tooling programs for Forum Plastics LLC.

Responsibilities/authority

  • Point of contact for all customer Supplier Change Requests (SCRs).
  • Review, analyze and work toward implementing solutions to customer complaints related to SCRs.
  • Direct customer communication regarding project quality requirements / deliverables (PPAP documents).
  • PPAP and/or validation document creation, review and final submission to customers.
  • Support the activities of the Engineering department in new tool programs to ensure compliance with the company Quality Policy.

job duties

  • Lead all SCR activities including customer calls, tooling modifications, sampling, inspection and final submission by working with Engineering, Tooling, Quality and Customer Service departments.
  • Keep abreast of current quality system requirements.
  • Lead and participate in continuous improvement projects within the Engineering and Manufacturing departments.
  • Review designs for gages, fixtures, and jigs as needed.
  • Aid in the development and implementation of Quality, Manufacturing and Engineering programs to improve overall operations.
  • Develops a Quality Plan for each product by working with Engineering and Metrology.
  • Facilitate / participate in meetings with customers and Project Engineers to review project status related to quality requirements.
  • Assist in the selection, ordering and implementation of new equipment, and facility improvements as required.
  • Participate in internal Quality Audit programs.
  • Develop and maintain a high level of communication with all departments within Forum Plastics LLC.
  • As needed, perform required inspections utilizing the Metrology inspection equipment and other traditional inspection devices as required.
  • As needed, prepare documentation for FAI packages, capability studies, Gage R&Rs and PPAPs using Minitab, Word and Excel.

Education:

  • BS degree in science or technical field, BSME or CQE/CQA preferred.

EXPERIENCE:

  • Minimum 3 years experience as a Quality Engineer or similar role, medical device industry preferred.
  • Minitab, Statistical Analysis Training.
  • Experience with ISO 13485:2016 a plus.
  • SPC, Lean Manufacturing, FMEA, GD&T Training preferred.
  • Experience in Manufacturing or Engineering Environment a plus.
  • Knowledge of plastic injection molding processes and qualifications related to medical devices a plus.
  • Strong knowledge of safety procedures and policies.
  • Knowledge of OSHA practices desirable.
  • SolidWorks proficiency a plus.
  • Microsoft Office skills required (Excel, Word, Project, Outlook).
  • Project Management experience a plus.

Personal characteristics

  • Excellent written and verbal communications skills.
  • A highly self-motivated person.
  • Strong computer and statistical analysis skills.
  • Mechanically inclined with a technical mindset.
  • Highly organized and detailed with a positive attitude.
  • Works well under pressure and pays close attention to details.
  • A strong sense of responsibility.
  • Strong willingness to learn.
  • Able to lead and participate on cross-functional teams / strong interpersonal skills.
  • Ability to manage multiple projects at a time.
  • Maintains a clean, safe and orderly workplace.

COVID-19 CONSIDERATIONS:

  • Masks are optional for employees and visitors
  • Personal protective equipment provided
  • Temperature screenings
  • Social distancing guidelines in place
  • Sanitizing, disinfecting, and cleaning procedures in place
  • Facility is disinfectant sprayed every week, also if a COVID case is identified
  • Visitors must be registered before entering the facility

reporting relationship:

  • Reports to Director of Engineering

LOCATION:

  • Waterbury, CT

job Type

  • Full-time

SCHEDULE:

  • Monday to Friday

BENEFITS:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Health insurance
  • Life insurance
  • Paid time-off
  • Professional development assistance
  • Referral program
  • Retirement plan
  • Vision insurance

Supplemental Pay

  • Bonus pay

Covid-19 Considerations

  • All employees and visitors must wear masks at all times. Visitors must be registered before entering the facility. Facility is disinfectant sprayed every week and if a COVID case is identified.