Quality Assurance Investigator

<strong>Quality Assurance Investigator </strong><br><br><strong>Onsite in Westborough, MA</strong><br><br><strong>6+ month initial contract</strong><br><br><strong>Hourly Pay Rate: $56-60/hr (Medical benefits available at a cost)</strong><br><br>Orion Group is seeking a skilled and detail-oriented Quality Assurance Investigator to work in Westborough, MA for our global scientific instrumentation manufacturer client.<br><br>We are seeking a meticulous and detail-oriented Quality Assurance professional to join our team. As a Quality Assurance Investigator, you will play a crucial role in ensuring the quality and compliance of products/services through meticulous inspection and adherence to regulatory standards.<br><br>If you are looking to build your career experience in the biotech industry helping researchers save lives through the development of new scientific technology and showcase your Quality Assurance skill set, read on!<br><br><strong>What you'll do:</strong><br><br>* Execute the triage, investigation, and closure of product quality complaints.<br><br>* Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.<br><br>* Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.<br><br>* 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.<br><br>* Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers<br><br><strong>Who you are:</strong><br><br>* Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or Master's level program<br><br>* Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required<br><br>* Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)<br><br>* Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance<br><br>* Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints<br><br><strong>Must have skills:</strong><br><br>* Pharmaceutical or medical device industry background<br><br>* Experience with Quality Management Systems (QMS)<br><br>* Technical Writing experience<br><br>* Complete management experience<br><br>Our role in supporting <strong>diversity</strong> and <strong>inclusion</strong><br><br>As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.