Quality Compliance Specialist
MedDev is seeking a full-time individual to join our team as a Quality Compliance Specialist. The individual will report to the Quality Manager to ensure compliance with domestic and international regulatory standards (FDA 21CFR820/QSR, ISO 13485, MDD 92/42/EEC). The individual will also work with Engineering on various facility, equipment, and materials projects. This multi-functional role and has growth potential for the right individual.• Develop and maintain quality assurance standards and processes; specifically, continue ISO13485
/ CE Mark certification..
• Manage document control including change control, document tracking, retrieval and archiving,
document routing and distribution of updates.
• Maintain design history files, including related archival files for device history records
• Write SOPs, Work Instructions, Forms, and Manufacturing Records as requested
to third party payers to encourage payment for MedDev products
• Manage and update current reference library of applicable regulations and standards
• Coordinate employee training requirements. Maintain and ensure training records are current
• Assist in employee training programs to ensure employee awareness of quality systems and standards
• Manage Corrective and Preventive Action documentation and Non-Conformance Reporting to ensure
• Oversee management of Internal Audit activities including audit scheduling and follow-up corrective
• Generate quality metrics
• Assist Engineering with manufacturing and material testing, equipment calibration and preventive
• Assist MedDev team members to devise solutions to quality issues
• Interface with regulatory authorities and our Notified Body
• Maintain regulatory clearances and approvals with necessary filings and communications
• Other duties may be assigned
Requires excellent proofreading, editing and technical writing skills MS Office (Word, Excel, PowerPoint, and Flow-Charting) and database management systems Good interpersonal and training skills Ability to communicate (written and oral) effectively with MedDev team members and with external parties (such as vendors) Ability to work independently with minimal direction and resolve issues Experience with Macola Progression ERP and Minitab Statistical software a plus
1-3 years in a quality/regulatory compliance role. Bachelors or AA degree. Additional education can offset experience requirement. Working familiarity with general processes, systems, workflows and procedures of a small regulated business (preferably medical devices) Working knowledge of current FDA 21CFR820, ISO 13485, MDD 93/42/EEC requirements
ABOUT MEDDEV CORPORATION
We are a small medical device company based in Sunnyvale, CA. We manufacture Class II surgical implants and Class I medical devices for the US, European, and Australian markets. Our company has been in continuous operation for forty-five years. Please visit our website at www.meddev-corp.com to learn more about our products and services.
MedDev offers a competitive compensation and benefit package including medical and dental insurance. For consideration please submit (1) Letter of interest (2) Resume (3) Salary expectations (along with salary history). Recent college graduates with a Bachelor’s degree in related fields (Business Management, Quality Assurance or Manufacturing Engineering) are encouraged to apply and should submit a brief summary of course completion.
In the subject line, please put “Quality Compliance Specialist”. MedDev is an equal opportunity employer.
730 North Pastoria Avenue
Sunnyvale, CA 94085
PH. (800) 543-2789/ (408) 730-9702 / (408) 730-9651
FAX. (408) 730-9732
Website: meddev-corp.com / www.hand-helper.com