Quality Engineer - FULL TIME
- 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.
- 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.
- 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.
- BS degree in science or technical field, BSME or CQE/CQA preferred.
- 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.
- 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.
- 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
- Reports to Director of Engineering
- Waterbury, CT
- Monday to Friday
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time-off
- Professional development assistance
- Referral program
- Retirement plan
- Vision insurance
- Bonus pay
- 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.