Full-Time
QA/RA Specialist II
Posted on 4/27/2024
HR consulting and talent management services
Consulting
Mid
Biddeford, ME, USA
Required Skills
Quality Assurance (QA)
Requirements
- Bachelor of Science degree in Life Sciences
- 5+ years of employment in a cGMP regulated facility
- 2+ years of experience in Quality Assurance
- Must be a nonsmoker
- Vaccinations for Covid required
- Excellent proof-reading skills
- Knowledge of current GMP regulations
- Strong skill in utilizing Microsoft Office software
- Technical writing skills
- Knowledge of ISO 13485
- Knowledge of In Vitro Diagnostic Regulation (IVDR)
- Experience in laboratory medicine
- Good communication skills
- Ability to meet challenging timelines
- Willingness to learn and pitch in as part of a team
- Capable of rapidly developing sufficient expertise to function independently
Responsibilities
- Reviews and approves all MMQCI Quality System documentation
- Works closely with all departments to investigate MRNs and establish CAPAs
- Reviews and approves validations of new equipment and processes
- Assists or performs internal audits and supplier audits
- Participates in internal, customer, FDA, and ISO audits
- Assembles Device Master Records for new products
- Writes SOPs and oversees training documentation for all MMQCI employees
- Maintains MMQCI’s ISO 13485 certification
- Prepares and submits FDA pre-submissions, de novo requests, and 510(k) submissions
- Interprets statutes, regulations, policies and guidance for MMQCI staff teams
- Remains current on regulatory issues/trends
- Provides training or presentations to cross-functional groups on various regulatory topics
KMA Human Resources Consulting offers professional HR consulting, recruiting, and compensation services, specializing in compliance, employee development, and talent management for businesses in New England. Their experienced team provides sound HR advice in employee relations, engagement, performance, and workforce training, with a customized approach to fit clients' requirements and budget.
Company Stage
N/A
Total Funding
N/A
Headquarters
Falmouth, Maine
Founded
2007
Growth & Insights
Headcount