FDA 21 CFR

Part 820, ISO 13485, and

ISO 9001

guidelines and regulations. This role will partner with the Management Team to drive compliance with customer requirements, external standards, and internal specifications/procedures.

What you will do:

Implements and maintains the Quality Management System (QMS) documentation system and associated processes while ensuring compliance with applicable standards, regulatory and customer requirements, and overall protection of company intellectual property. Monitor the Document Change Control Request process and ensures the process is performing as stated in the applicable Work Instruction (WI). Authors and updates controlled documents and specifications, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and Internal Specifications, following established processes to ensure revision control records are maintained. Assures control of quality records (including records retention) are compliant with procedures and applicable Work Instructions. Initiates and maintains periodic review of controlled documents per company procedure. Manages training program, granting employees access and assuring all training records are current to employees' curriculum, conducts orientation training for Quality. Work with Quality Management to ensure that documents are released and become effective. Assists in internal/external audits and supplying documents as applicable. Supplies applicable Metric Data as requested. Maintains off-site storage of records including requesting pickups, ordering boxes, etc. Performs other activities and other projects as requested by RA/QA Management.

Who you are:

High School Diploma or GED Equivalent; in the absence of a diploma or 4-year degree, applicable years of experience are required. Two (2) to three (3) years of relevant work experience in an ISO or FDA-regulated environment. Must have hands-on experience developing or maintaining a QMS or controlled document system in a regulated industry. Effective communication skills, ability to prioritize tasks, and attention to detail. Ability to work independently under minimal supervision and/or as part of a team. Sound knowledge of GMP and GDP requirements. Proficiency with Microsoft Office Suite including Word, PowerPoint, and Excel. Perks /

Benefits:

Generous Paid Time Off Paid Breaks Annual Bonus 401(k) with excellent company match Health Insurance with multiple plans to choose from Paid Short Term and Long Term Disability Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. 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