Natick, MA | Full-time
The Quality Systems Specialist is responsible for contributing to all aspects of planning, developing, and improving the Pillar Quality Management System, with a primary focus on Document Management. The role will allow the candidate to participate in Quality Systems (e.g., CAPA, internal audit, document/change control), Design Assurance (e.g., aid in the authoring design and development deliverables, participate in design reviews, etc.), and Manufacturing Quality (nonconformities, manufacturing flow mapping) activities.
Opportunities will be available for the candidate to take on additional areas of responsibility based on interest. The candidate must be motivated, a quick-learner, with strong technical writing skills and have the ability to work under minimal supervision. While the work is plentiful and challenging, the atmosphere is friendly and relaxed; a sense of humour is appreciated.
Duties and Responsibilities
- Own the Document Management Process, including, managing document changes, Change Orders, and QMS Change Orders within the eQMS.
- Aid in maintaining other Quality processes such as the CAPA, SCAR, NCMR and complaints processes.
- Generate and revise Standard Operating Procedures, Work Instructions, and other quality systems documentation.
- Revise training requirements (and work with HR on implementing said requirements) for Quality Management System activities, including SOPs
- Generate metrics for critical-to-quality process
- Participate in and drive quality and process improvement initiatives and project teams.
- Participate in internal and external audits as required
- Assist and collaborate with other department such as Manufacturing, Quality Control, Clinical Affairs, Service and Regulatory to ensure continued compliance, product quality, and safety
- Aid in addressing issues related to quality concerns, implementing effective solutions and corrective actions
- Review and approve internal CAPAs, Change Controls, Deviations, and other quality processes
- Assist in Product Complaint investigations, Material, Change Review Boards as needed.
- Other duties, as required
Bachelor’s degree or higher in Science or Engineering field, or related technical field; or equivalent combination of education and experience.
Experience, Knowledge, Skills and Abilities:
- Two to five years QA experience in an ISO 13485 Certified or FDA regulated company
- IVD, molecular diagnostics/NGS, and/or software product experience
- Previous FDA submissions experience
- Previous exposure to compliance to European IVD regulations and directives (IVDD, IVDR)
- ASQ certification (e.g., CQPA, CQIA, CQE, CQA, CQT)
- In-depth knowledge of ISO 13485, and FDA QSR
- Functional knowledge of the IVDD and IVDR is considered an asset
- Experience working in a regulated environment
- Bring a team spirit and problem-solving attitude
- Competent in use of Microsoft Office software (Word, Project, Excel, Visio, PowerPoint)
- Familiarity with SAP or analogous Enterprise Resource Planning software systems, Qualtrax electronic document system, CAPA software systems, and quality improvement processes
This position is conducted in an office environment. Must be able to perform work while sitting or standing for long periods of time. Work may at times require repetitive movements.
- Reports to: Quality Assurance Manager
- Direct Reports: 0-3
- Location: Natick, MA
- Classification: Experienced, non-manager or manager
- Travel: 0-5%
- Status: Full-time
We offer a competitive compensation and benefits package that includes medical and dental insurance, paid vacation, 401(k), and more. For more information visit www.pillar-biosciences.com. Pillar Biosciences Inc. is an Equal Opportunity Employer.