Quality Engineer

Belmar, New Jersey
Manufacturing & Production
Job Type
US$ 25.00 - US$ 29.00 per hour, $25 - 29 per hour + none
Ref. Number
Lubischer, Gabrielle, Spherion
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Job Description

Quality Engineer is responsible for supporting validations, qualifications, Quality Plans, supplier selection, evaluation and SCAR issuance. Participates in review and approval of Quality System documents, resolves quality issues and ensure quality control of products and processes, in compliance with all applicable company policies and procedures.

- Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
- Meets commitments on time with accuracy and attention to detail.
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents. Provide interpretive assistance, to all departments, regarding these documents.
- Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified.
- Design, execute, and document gage R&R studies.
- Support training on Manufacturing and Quality System documents.
- Quality Representative for Material Review Board (NMR).
- Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
- Develop validation and/or verification protocols; execute validations/verifications and report on the conclusions to support new product development or process improvements.
- Release documents via the change control process as necessary. Train others where required.
- Support, investigate, determine root cause and respond to customer complaints and customer issued SCARs.
- Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols).
- Prepare and execute Engineering studies as needed.
- Participate in CAPA root cause investigation and actions implementation.
- Implement ongoing quality improvement processes working with cross functional teams.

Working hours: 8:00AM - 5:00PM

--A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge.
--Basic knowledge of ISO 13485:2016 and FDA QSR.
--Experienced root-cause investigator and problem solver within a manufacturing environment.
--Mechanical aptitude with manufacturing experience.
--Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos.
--Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
--Well versed in data management and graphical presentation of data.
--Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
--Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization.

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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