Quality Engineer

1 week ago

Campbell, United States inSync Staffing Full time

Pay $65.00-$75.00 W2 (no 1099 or C2C)
2 month + assignment

EDUCATION/EXPERIENCE:
• BS in Engineering or related discipline and 8+ years of supplier quality experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Lead development and validation of test methods to comply with recognized standards
• Must have experience with catheters, endovascular or neurological devices
• Must have demonstrated ability to perform multiple tasks concurrently with accuracy
• Experience leading supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)
• Must have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485), risk management standards (ISO 14971) and good manufacturing practices
• Excellent communications skills (both written and verbal)
• Must be able to provide thorough and meticulous review of documents
• Must be able to write clear, concise, and well thought out technical documentation.
• Proficiency with Microsoft Office products
• Ability to communicate effectively, both orally and in writing, with all organizational levels
• Strong attention to detail and ability to function in a fast-paced dynamic environment
Provide Supplier Quality Engineering support in the development, manufacture, and distribution of medical device products consistent with the Company's Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA and other governmental regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
• Lead component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups.
• Manage and raise supplier issues when intervention or a change at a supplier.
• Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
• Support internal and supplier related NCMR and CAPA. Drive corrective actions for supplier process by assisting suppliers to true root cause analysis and CAPA
• Plan, conduct, report and follow-up on supplier quality system audits
• Drive and execute supplier quality agreements
• Partner with Procurement, R&D, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
• Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
• Apply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for supplier quality management (SQM) projects.
• Apply analytical and problem-solving skills to develop and optimize supplier performance.
• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.
• Develop/implement Quality Risk Management process for supplier-related matters with partnerships of subject-matter-experts (SME)
• Responsible for presenting supplier-related issues or opportunities to next management level
• May provide quality metric data to various functional groups within the organization
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
• Actively promote and support the company's Management Review process.
• Inform responsible personnel of concerns involving product quality.

Benefits (employee contribution):

  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

#IND12

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