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Job Title: Senior Quality Management Systems Engineer Company: Precision Optics Corporation Location: Gardner, MA (occasional travel to Littleton, MA) Employment Type: Full-time Salary: \$110,000 - \$135,000/year Position Summary: The Senior Quality Management Systems (QMS) Engineer is responsible for maintaining, improving, and ensuring compliance of Precision Optics Corporation?s QMS to ISO 9001, ISO 13485, FDA 21 CFR Part 820, MDR, MDSAP and other applicable regulatory requirements. This role leads continuous improvement, audit support, CAPA/NCMR/complaint management, documentation control, training, supplier quality, and design assurance activities to ensure product quality and regulatory compliance. Principal Responsibilities Quality System Maintenance & Compliance - Maintain, improve, and ensure compliance of the QMS to ISO 9001, ISO 13485, FDA QSR, MDR, MDSAP and other applicable regulations. - Develop, revise, implement, and maintain QMS documentation including SOPs, work instructions, forms, and specifications. - Monitor quality data, develop metrics, prepare actionable reports, and support Management Review. - Initiate and drive QMS improvements. Audits, CAPA, NCMR, and Complaints - Prepare for and support internal, supplier, and external audits (FDA, Notified Body, customers). - Manage/support CAPA, Nonconforming Material Reports (NCMR), and complaint handling. - Perform internal audits, lead root cause analysis, verify effectiveness, and track closure of corrective actions. - Perform trend analysis and continuous monitoring of quality issues. Training & Documentation - Oversee document control, record management, and electronic QMS tools. - Support and deliver QMS training to ensure employee competency to applicable documentation and requirements. - Participate in change control and regulatory impact assessments. Design Assurance & Risk Management - Support product development teams to ensure design control requirements are met. - Support risk management activities per ISO 14971. Supplier Quality - Perform supplier evaluations and audits as appropriate and support supplier performance monitoring and improvement. Requirements Experience & Knowledge - 8+ years quality engineering experience in the medical device industry (defense/aerospace and manufacturing engineering experience a plus). - Fluent knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, MDSAP, and MDR. - Experience with electronic QMS platforms (e.g., QCBD, MasterControl, Arena, etc.). - Proficient in Microsoft Office 365 (Word, Excel, PowerPoint, Access, Teams, SharePoint). - Familiarity with ERP and PLM systems preferred. Competencies - Project management and leadership skills; proven experience leading investigations and implementing effective corrective actions. - Excellent verbal and written communication; ability to interact at multiple organizational levels. - Strong organizational skills, attention to detail, and ability to prioritize multiple tasks and deadlines. - Data analysis skills: develop metrics, identify trends, and produce actionable reports for Management Review. - Able to work both independently and as part of cross-functional teams in a fast-paced environment. Education - Bachelor?s degree in engineering or related technical field, or equivalent combination of education and experience. - Advanced degree or certifications (e.g., ASQ CQE, CQA, ISO 13485 Lead Auditor) preferred. Supervisory Responsibility - None. Working Conditions - Office and controlled manufacturing/engineering laboratory environments including ISO Class 7 cleanrooms; PPE required in controlled areas. - Occasional travel between Gardner and Littleton, MA for audits or supplier activities. Equal Employment Opportunity Precision Optics Corporation is an equal opportunity employer. Applicants from diverse backgrounds are encouraged to apply.