Location
Westborough, MA | United States
Job description
Job Title: Quality Auditor
Location: Westborough, MA
Pay: up to $55/hr. (DoE)
Area Code: 508
Zip Code: 01581
Start Date: ASAP
Keywords: #quality, #audit, #manufacturing
A Quality Auditor job in Westborough, MA is currently accepting applications. This is a 6 month contract position with our key biotechnology client. In this role, you will be responsible for performing Failure Mode trends to identify emerging issues across various Westborough product groups and provides analysis around failure mode signals, root cause investigations, and subsequent corrective action. To be considered for this role, you will have a B.S. Degree in Engineering, along with 7+ years of related experience.
Quality Auditor Job Responsibilities:
- Interface with customers in various forms of communications including regional forums and specific customer touchpoints, as requested by various teams in the field
- Provide data and analysis for customer specific meetings.
- Proactive Failure Mode Trending to identify emerging issues across various product groups and provides analysis around failure mode signals, root cause investigations, and subsequent corrective actions
- Support in CHU complaint handling and QA product investigations as deemed appropriate by management
- Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.
- Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers
Quality Auditor Job Requirements:
- Bachelor"s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master"s level program
- Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required
- Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
- Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance
- Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints
If you are interested in this Quality Auditor job in Westborough, MA, please apply via the 'apply now' link provided.
Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the engineering, IT, and professional fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at
EOE/F/M/D/V
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