Quality Assurance Specialist MedDev Corporation Sunnyvale, CA Job Details Temporary 13 hours ago Benefits Paid time off Qualifications Microsoft Excel Data collection Training & development Manufacturing Root cause analysis Full Job Description Company Overview MedDev Corporation is a leading manufacturer of innovative, high-quality surgical and rehabilitation healthcare products. For more than five decades, the company has specialized in ophthalmic devices and resistive hand therapy products that support patient outcomes and quality of life. Job Overview We are seeking a detail-oriented Quality Assurance Specialist for a temporary role. You will work with our team to support quality system improvements, and compliance activities, update documentation identified in gap assessments and ensure MedDev products meet FDA quality expectations and support continuous improvement initiatives. The ideal candidate will bring strong knowledge of medical device quality standards, regulatory compliance, and manufacturing processes. Responsibilities Lead quality system procedure and document revisions identified through gap assessments against applicable standards, including 21 CFR Part 820/QMSR and
ISO 13485.
Manage document control activities, including change control, document tracking, retrieval and archiving, routing, and distribution of approved revisions. Coordinate employee training requirements and maintain accurate, current training records. Manage internal audit activities, including audit scheduling and follow-up corrective actions, to ensure ongoing compliance with regulatory standards, including FDA QMSR and
ISO 13485.
Maintain detailed documentation of audits, inspections, nonconformances, and corrective and preventive actions to support compliance audits and continuous improvement efforts. Support complaint handling investigations, data collection, root cause determination, risk assessment, corrective action planning, and effectiveness verification. Support post-market surveillance data collection and transfer activities for use in risk assessment. Support supplier evaluation and verification activities, including purchasing quality agreements, new supplier quality agreements, and supplier risk assessment classification. Support design control activities, including risk-based modifications to design inputs and outputs, verification, and validation. Provide oversight of routine manufacturing, material testing and monitoring, equipment calibration, and preventive maintenance activities. Participate in Management Review, report on quality metrics, trends, and systemic issues, and support continuous improvement outputs. Preferred Experience Bachelor's degree in life sciences, engineering, quality, or a related field. Minimum 5 years of related work experience in a quality/regulatory assurance role within a regulated industry. Extensive understanding of the risk-based approach under 21 CFR Part 820/QMSR and
ISO 13485.
Proficient in updating procedures and processes to close identified gaps. Proven experience conducting internal and external quality audits. Working familiarity with general processes, systems, workflows, and procedures of a small regulated medical device company. Preferred Skills Excellent proofreading, editing, and technical writing skills. Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and flowcharting tools. Strong interpersonal and training skills. Ability to communicate effectively, both orally and in writing, with MedDev team members and external parties such as vendors. Ability to work independently with minimal direction and resolve issues effectively. Experience with Macola Progression ERP and Minitab Statistical software is a plus. MedDev offers a competitive compensation package for this temporary position, based on experience and qualifications. MedDev is an equal opportunity employer.
