Quality Assurance Engineer Position Available In Onondaga, New York
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Job Description
214713 – Quality Assurance Engineer
Industry
ENG
Region
NY-Upstate
City
Skaneateles
State
NY
Rate
Up to $53.03 DOE
Duration
6 months
Description Chipton Ross is seeking a Quality Assurance Engineer for a contract opportunity in Skaneateles, NY.
JOB SUMMARY
We are seeking a Systems or Quality Engineer to be responsible for integrating design procedures, templates, and guidance documents within our client’s
ISO 13485
compliant Quality Management System (QMS). The successful candidate will have a working knowledge of FDA/ISO regulations, specifically
ISO 13485
(7.3) and 21 CFR 820.30, and the application of Good Documentation Practices. Demonstrate ability in writing quality system procedures. The ideal candidate will have a demonstrated ability to communicate with a wide range of stakeholders, including Quality, Systems/Risk, Project Management, Regulatory Affairs, Marketing, and others.
BASIC QUALIFICATIONS
(REQUIRED
SKILLS/EXPERIENCE
):
1. Medical Device experience
2. Knowledge of ISO 13483 and 21 CFR 820.30
3. Experience writing Standard operating procedures (SOP’s)
4. Strong writing and communication skills
5. Knowledge of Agile Product Lifecycle Management Tool preferred
6. Knowledge of SAP Tool preferred
POSITION RESPONSIBILITIES
o Complete SOP gap assessments for process integration focused on the Front Line Care division.
o Participate in ‘deep dive’ reviews of selected procedures with Subject Matter Experts (SMEs). Ensure that process details driven by prior corrective actions are reviewed and maintained as appropriate.
o Write/update, review, analyze, and revise Standard Operating Procedures (SOPs), work instructions, forms, templates.
o Drive reviews/approvals of SOPs with cross functional Subject Matter Experts (SME’s).
o Monitor actions for proper SOP implementation.
o Report periodic integration status to stakeholders.
o Work with different functional groups and produce appropriate documentation in support of SOP integration.
o Strong verbal and written communication skills, documentation practices, be self-motivated and possess strong interpersonal skills.
o Excellent problem-solving skills and attention to detail.
REQUIRED EDUCATION
Relevant Bachelor’s Degree required
WORK HOURS
First Shift, Full Time Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date. Contact
Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone:
(310) 414-7800 x307 or (800) 927-9318 x307 Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please. Employment will be contingent on candidate clearing pre-employment drug screen and background check. Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations. © 2025 Chipton‑Ross Inc. All rights reserved
