QUALITY ENGINEER – FULL TIME

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.

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.

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.