Quality Assurance Specialist

MMQCI•Saco, ME

About The Position

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.

Requirements

Bachelor’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

Responsibilities

Review 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 reviews and authorizes process and equipment validations
Performs or assists with audits, including internal, customer, and regulatory audits
Maintains MMQCI’s ISO 13485 certification
Writes SOPs and trains key personnel as needed to support all departments
May be called on to assist others and perform additional tasks as assigned