Job Description
Title: Quality Assurance Associate II
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Description:
We are seeking a Quality Assurance Associate II to support Quality Management System (QMS) activities within a regulated medical technology/life sciences environment. This role will have a strong focus on CAPA management, investigations, root cause analysis, technical writing, and overall QMS compliance.
The ideal candidate is naturally curious and inquisitive, has excellent written communication skills, and is comfortable digging into quality issues to identify root causes and drive effective solutions. Were looking for someone who is collaborative and persistent and can confidently ask difficult questions when necessary to ensure quality and compliance.
Responsibilities:
Qualifications:
Preferred Qualifications:
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Temp or Temp-to-Hire
- Pay rate: $30$40/hour
- Job Location: Providence, RI (preferred) or Raleigh, NC
- Work Model: Onsite preferred; hybrid may be considered
- Schedule: MondayFriday, 8:30 AM5:00 PM
Description:
We are seeking a Quality Assurance Associate II to support Quality Management System (QMS) activities within a regulated medical technology/life sciences environment. This role will have a strong focus on CAPA management, investigations, root cause analysis, technical writing, and overall QMS compliance.
The ideal candidate is naturally curious and inquisitive, has excellent written communication skills, and is comfortable digging into quality issues to identify root causes and drive effective solutions. Were looking for someone who is collaborative and persistent and can confidently ask difficult questions when necessary to ensure quality and compliance.
Responsibilities:
- Perform day-to-day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring due dates, and responding to quality-related requests.
- Participate in and write CAPA investigations, root cause analyses, corrections, corrective actions, and preventive actions.
- Log, triage, and perform initial risk assessments of reported quality events and observations.
- Compile, analyze, and present QMS performance metrics, including CAPAs, audits, nonconformances, and other quality indicators.
- Support complaint handling, supplier evaluations, and other QMS activities.
- Participate in internal and external audits, including audit preparation, documentation coordination, and responses to auditor inquiries.
- Track quality actions and investigations through completion while ensuring established timelines are met.
- Identify opportunities to improve QMS efficiency, compliance, and effectiveness.
- Collaborate with internal teams and stakeholders to investigate and resolve quality issues.
Qualifications:
- 25 years of relevant Quality Assurance experience in a regulated industry; medical device or life sciences experience preferred.
- Strong technical and business writing skills with the ability to clearly document investigations and quality-related information.
- Experience with CAPA, investigations, root cause analysis, and Quality Management Systems.
- Familiarity with ISO 13485 and/or Quality Management System Regulation (QMSR) requirements.
- Strong investigative skills and a genuine interest in understanding why issues occur.
- Ability to independently manage assigned tasks from initiation through completion.
- Collaborative and persistent approach with the ability to navigate challenging conversations.
- Strong computer literacy, including experience with electronic systems, databases, and standard business software.
- Bachelors degree in business, engineering, life sciences, or a related technical discipline preferred, but not required.
Preferred Qualifications:
- ISO 13485:2016 Internal Auditor Certification.
- Front-room or back-room audit experience.
Numbers & Facts
| Location | Providence, RI |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | https://www.csetalent.com/ |
About Company
Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity. Over the last 20 years Connexion has built the most admired team of staffing experts in the industry. We give back, change lives and offer unconditional support to the candidates we represent.
Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.
Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want
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