["Quality Assurance Specialist","Quality Assurance Specialist"]

Ensure Quality & Compliance as Our Next QA/RA Specialist!The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with applicable regulatory requirements. Reporting to the Manager of QA/RA, this position is responsible for maintaining policies and managing procedures that support MMQCI's Quality System in alignment with ISO 13485 standards. The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems. This role offers the opportunity to quickly build expertise while working in a collaborative environment.What You Will Get to DoReview and approve all Quality Management System documentation (i.e. batch records and QC testing) to ensure compliance with QMS certifications and investigations.Collaborate with departments to investigate Material Review Notifications and develop Corrective and Preventive Action plans.Independently review and authorize process and equipment validations.Perform or assist with audits, including internal, customer, and regulatory audits.Maintain MMQCI's ISO 13485 certification.Write SOPs and train key personnel as needed to support all departments.May be called on to assist others and perform additional tasks as assigned.Required Skills & ExperienceBachelor's degree in Life Sciences with 5+ years' experience in a cGMP-regulated environment, including at least 2 years in Quality Assurance.Knowledge of current GMP regulations, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is preferred.Strong written and verbal communication skills; proficient in Microsoft Suite.Excellent proofreading skills with strong attention to detail.Ability to manage multiple priorities in a fast-paced, changing environment and meet challenging deadlines.Strong work ethic, team-oriented mindset, and willingness to learn.Ability to communicate clearly and constructively.Must be able to lift up to 30 lbs.Why You'll Love Working HereOpportunity to make a meaningful impact within a growing diagnostic company.Collaborative, mission-driven team environment.Competitive compensation and benefits.Benefits We OfferMedical, dental, and vision insurance.401(k) retirement savings plan.Company profit sharing program.Paid time off, including vacation, holidays, and sick leave.Paid Parental Leave Program.#J-18808-Ljbffr