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Quality Assurance and Regulatory Compliance Specialist II

2 months ago

Saco, Maine, United States MMQCI Full time
POSITION TITLE:
Quality Assurance/Regulatory Affairs Specialist II

GENERAL SUMMARY:

The Quality Assurance/Regulatory Affairs (QA/RA) Specialist II plays a crucial role in overseeing quality assurance and ensuring adherence to relevant regulatory standards. This position involves conducting audits and meticulously reviewing and analyzing documentation and data.

Reporting to the QA/RA Manager, the QA/RA Specialist II is tasked with the implementation, management, and upkeep of policies, procedures, and systems that guarantee compliance with MMQCI's Quality System, aligned with federal Quality System Regulation 21CFR820.

The ideal candidate will possess a robust background in the in vitro diagnostic industry and demonstrate proficiency in maintaining a Quality System compliant with 21CFR820. It is anticipated that the QA/RA Specialist II will quickly acquire the expertise necessary to operate independently.


PRINCIPAL DUTIES AND RESPONSIBILITIES:

Key responsibilities include:

  • Reviewing and approving all MMQCI Quality System documentation to ensure alignment with established procedures and regulatory requirements, including Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs), and Corrective and Preventive Actions (CAPAs).
  • Collaborating with various departments to investigate MRNs and develop CAPAs that address root causes.
  • Reviewing and approving validations for new equipment and processes.
  • Assisting or conducting internal and supplier audits.
  • Supporting FDA and customer audits.
  • Compiling Device Master Records for new products.
  • Overseeing training documentation for all MMQCI personnel.

Maintaining MMQCI's ISO 13485 certification and contributing to Technical Files for CE marking of MMQCI products while ensuring international product registrations are up to date.

Preparing and submitting FDA pre-submissions, de novo requests, and 510(k) submissions for MMQCI's Class II products while maintaining relevant FDA registrations.

Interpreting regulations, policies, and guidance for MMQCI teams, effectively communicating their implications for product development, manufacturing, and marketing.

Staying informed on regulatory trends affecting MMQCI products and assessing their impact on QA/RA colleagues and product development teams.

Participating in and potentially leading internal, customer, FDA, and ISO audits.

Collaborating with QA/RA and other MMQCI staff to review and approve product labeling changes, promotional materials, non-conforming product rework, CAPA closures, Customer Complaint resolutions, and Medical Device Reports (MDR).

Providing training or presentations on various regulatory topics to cross-functional teams.

Drafting SOPs and training key personnel as necessary.

Performing additional duties as assigned, including monitoring, maintaining, and enhancing the quality system, and serving as the responsible individual for post-market surveillance, reporting, and recalls.


MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
Education Requirements:

A Bachelor of Science degree in Life Sciences is required, along with a minimum of 5 years of experience in a cGMP regulated environment and at least 2 years in Quality Assurance.

Essential skills include:

  • Excellent proofreading abilities and a thorough understanding of current GMP regulations.
  • Attention to detail and knowledge of ISO 13485.
  • Familiarity with In Vitro Diagnostic Regulation (IVDR) is preferred.
  • Strong communication skills, both written and verbal, along with proficiency in computer applications, including Excel.
  • Capability to manage multiple tasks in a dynamic environment with shifting priorities.
  • A strong work ethic and the ability to meet demanding timelines despite challenges.
  • A willingness to learn and collaborate effectively as part of a team.
  • Ability to communicate constructively to address non-conforming behaviors and practices.

Note: Candidates must be non-smokers due to product contamination prevention requirements.


BENEFITS:
  • Medical insurance
  • Dental insurance
  • 401(k)
  • Profit sharing plan
  • Vacation
  • Holidays
  • Sick leave