Supplier Quality and eQMS Specialist
About The Position
The Supplier Quality and eQMS Specialist is part of a team supporting the development and commercialization of FDA-registered medical devices. The role interacts with functional areas across OVIK Health and assists with the daily management and maintenance of its medical device quality system, as well as supplier quality activities across OVIK Health locations. The position is on-site at the Mayflower Plant in Salisbury, Massachusetts, and reports to the Quality Assurance Manager, Mayflower Plant. The specialist manages supplier quality processes, serves as the quality contact for critical suppliers, and supports supplier approvals, deviations, corrective actions, contract-manufacturer batch release, sterility programs, and quality release testing. The role also supports the division’s quality management system, participates in management reviews, and performs other quality and regulatory tasks as assigned. For the medical device quality system, the specialist assists with implementing and maintaining a system based on ISO 13485 and FDA Quality System Regulation requirements. Responsibilities include document control, serving as the Greenlight Guru eQMS subject matter expert, monitoring CAPAs, customer feedback, and nonconformances, maintaining procedures and training, reviewing batch records, supporting product inspection and release, and participating in product development and audit activities. The position operates in a manufacturing facility and is designated safety-sensitive, with regular work around moving mechanical parts and powered industrial vehicles.
Requirements
- High school diploma.
- Strong verbal and written communication skills.
- Excellent Microsoft Word, Excel, Outlook, and PowerPoint skills.
- Ability to work in a fast-paced environment.
- Self-starting approach and ability to work within a team environment.
- Willingness to travel to the Spartanburg, South Carolina headquarters, OVIK Health manufacturing locations, and supplier locations as needed.
Nice To Haves
- Knowledge of ISO 13485 and FDA quality systems.
- Medical device manufacturing experience.
- English and Spanish proficiency, spoken and written.
Responsibilities
- Manage supplier quality processes, including risk evaluations, audits, quality agreements, and annual performance reviews across OVIK Health locations.
- Serve as the primary Quality Point of Contact for critical suppliers.
- Manage supplier deviations and approvals.
- Manage and execute batch release activities for contract manufacturers.
- Manage supplier corrective action requests.
- Support the division’s sterility program, including quarterly dose audits, annual reviews, and dose mapping.
- Support the effectiveness of the division’s quality management system and assist with other quality and regulatory tasks as needed.
- Participate in Management Review to help ensure supplier quality meets quality objectives.
- Conduct quality release testing across the division as needed.
- Assist with implementation and maintenance of a quality system based on ISO 13485 and FDA Quality System Regulation requirements.
- Control quality-system documentation for Salisbury, Portsmouth, and division-wide documents.
- Serve as the subject matter expert for the Greenlight Guru electronic Quality Management System.
- Monitor CAPAs, customer feedback, and nonconformances to ensure program effectiveness.
- Identify quality issues and communicate them to management.
- Maintain quality-system procedures and ensure required documents are properly controlled.
- Assist in developing and maintaining quality-system training for appropriate quality processes.
- Assist in implementing new inspection, measurement, and testing systems for quality monitoring and improvement.
- Track and report significant quality deviations.
- Conduct batch record and Device History Record reviews, including sterile records.
- Assist with quality inspection and product-release programs throughout production.
- Participate in new product development to help ensure appropriate quality assurance and control plans are in place before manufacturing begins.
- Participate in internal, external, supplier, and FDA audit activities.
- Perform other responsibilities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
