Validation Engineer III
Alphatec Spine
Quality Control Manager
Samsung NeuroLogica
full-time
Posted on:
Location Type: Office
Location: Danvers • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Manage daily QC operations including in process checks during manufacturing and final release of imaging systems
- Responsible for QC testing including (system and software) verification and validation for design changes and manufacturing improvement
- Investigate and document nonconformances, deviations, and product defects; lead root cause analysis and corrective actions
- Define, maintain, and improve QC documentation and processes to meet U.S. FDA 21 CFR 820 (FDA QMSR), MDSAP, EU MDR, ISO 14971 and ISO 13485 requirements
- Testing for sub-assemblies and system level testing for finished products
- External safety testing for changes at system level, critical components and end of life parts
- Generate appropriate metrics to quantify product quality including maintaining analysis of failing components, subassemblies and other issues
- Facilitate failure analysis and field defect analysis along with trending information
- Serve as a liaison providing quality engineering expertise for continuous process improvements for engineering, service and manufacturing personnel
- Review and verify product labeling
- Work with and respond to inquiries from regulatory agencies and assist with audits and inspections
- Contribute directly or manage designee to product ship reviews
- Direct the Incoming Inspection process of first articles, populated board assemblies and cable assemblies
- Provide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements
- Assist with initiatives in the quality department to meet corporate goals and ensure compliance with medical device regulations
- Assist with preparing field action documentation and executing the field action process
- Promote teamwork and collaboration within the quality function and with other functional areas
- Facilitate risk management activities (RMF, Risk/Benefit, planning, etc.) as needed for all products to ensure compliance with regulating bodies
- Create updates for Management Review Meeting and communicate clearly with company personnel, vendors, regulatory agencies, auditors and customers as required
Requirements
- Bachelor’s in Engineering, Quality or related field preferred
- 7+ years of related experience in the Quality Control / Quality Assurance, with 3+ years in a leadership role in the medical device or imaging industry
- Strong knowledge of ISO 13485 / MDSAP / EU MDR
- Strong technical understanding of imaging system performance testing and regulatory compliance
- Familiarity with IEC 60601-1 standards for Medical Devices safety, EMC and usability requirements
- Expertise in the use of Risk Management requirements via ISO 14971
- Ability to communicate effectively with engineers, assemblers, and management through all media
- Skills and expertise for creating, revising SOPs and providing employee training
- Technically savvy; able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
- Excellent written, oral, and documentation skills
- Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
- Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment
- Proficiency with MS Office package, including Excel, Word, PowerPoint, and Outlook
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire
Benefits
- 4 Different Blue Cross/Blue Shield Medical Plans to meet your needs
- Dental coverage through BlueCross/Blue Shield Dental
- Vision coverage by Blue Cross/Blue Shield
- Company paid Short-term and Long-term Disability coverage
- $1 for $1 401k match up to 5% managed by Fidelity
- Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more!
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
QC testingverification and validationroot cause analysiscorrective actionsrisk managementproduct validationequipment calibrationfield action documentationSOP creation and revisionimaging system performance testing
Soft skills
communicationteamworkcollaborationanalytical skillsleadershipproblem-solvingadaptabilitytrainingproject managementattention to detail
Certifications
Bachelor’s in EngineeringQuality certification
