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Quality Assurance Engineer in Southbridge, MA at Expert Staffing Inc

Date Posted: 8/2/2018

Job Snapshot

Job Description

Job Purpose

Quality Representative Leader in new product development projects which focuses on validation of implantable and non-implantable plastic medical devices and supporting equipment’s.

Duties and Responsibilities

•          Develop and  approve validation strategies, (Installation Qualification, Operational Qualification, Performance Qualification, Equipment Installation Qualification, Design of Experiment, Gage R&R)  protocols and reports for products and equipments  using engineering experience and statistical techniques.

•          Work with Manufacturing Engineer and Lead Inspector prior to protocol executions and ensure expeditious and accurate completion of validation.

•          Interact regularly with General Manager, QA Manager and customers on validation activities progress. Key Participant of weekly meetings with Project Manager, QA Manager and Manufacturing Engineer to update customer on validation activities.

•          Conduct design of experiments and applies statistical techniques (T-test, control charts, Multi Vari charts, Process Capability (Cpk, Ppk), Gage “Repeatability & Reproducibility” (R&R) to improve molding processes capability and robustness.

•          Maintain validation records to ensure compliance with current standards.

•          Use flowchart to develop process and evaluate failure modes.

•          Develop and Lead FMEA's and Production Control Plan.

•          Summarize and evaluate protocol data involving resolution of discrepancies and exceptions as required for completion of validation summary reports.

•          Balance successfully the workload of multiple projects simultaneously while assuring high quality deliverable with aggressive schedules.

•          Plan, schedules inspection and test with QA Manager and evaluate the adequacy of activities to accomplish inspection objectives.

•          Facilitate first piece inspection for new product development.

•          Drive revalidation efforts to ensure systems continue to meet regulatory requirements

•           Review, update and write all documents (such as work instructions, inspection instructions).

•          Participate in Contract Reviews for validation documents

•          Work with Manufacturing and Engineering/Tooling to identify and drive improvement opportunities.

•          Act as a project leader for process improvement projects, conduct and/or review results of investigation analyses issues, and collect data, monitor and report process trends and control data, and coordinate product and process transfers.

•          Assure quality programs are designed to achieve customer specification and continually evaluate quality assurance and/or control methods.

•          Perform and Participate in 3rd party ISO 9001:2008 and ISO 13485:2003 audits (Risk Management). Conduct ISO 9001:2008 and ISO 13485:2003 internal Audits.

•          Assure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO and GMP standards.

•          Work with Inspectors.

•          Perform inspections when needed.

•          Perform other duties as assigned

Job Requirements

Skills / Qualifications

•          Bachelor’s Degree or equivalent, or 3-5 years’ related  experience and/or training , or equivalent combination of education and experience in quality engineering  in the medical industry

•          Strong Computer skills; Microsoft Office ( Word, Excel)  and Minitab

•          Must have a strong attention to details

•          Leadership skills and team player

•          Highly organized

•          Ability to  work with a high volume of documents in a fast paced environment

•          Strong written , verbal , time management and interpersonal skills

•          Knowledge of GD&T print interpretation , CAD Models , Statistical technique and Software , Programming CMM’s , Validation Activities ( IQ, OQ,PQ) , Cleanroom practices , Sampling Technique.

Physical Requirements

•          Must be able to lift up to 25 lbs. 

•          Must be able to sit or stand for long periods of time

•          Must be able to climb up and down stairs

Other Special Requirements

•           Support cross functional teams and departments as required  

•          Travel is required to support company initiatives

•           Perform job duties in accordance to ISO 13485/9001 including ISO audits

Safety Responsibilities

•           Ensure that all safety procedures are followed

•           Ensure that all equipment safeties are not altered or defeated.