Senior Quality Engineer

Description

Position Summary

The successful candidate will be a quality engineer with experience in the medical device industry who can demonstrate the ability to ensure that our suppliers meet all quality standards.

Job Responsibilities

• Understand and optimize the processes and systems for supplier quality management, and ensure they are aligned with the company’s objectives and the customer’s needs.
• Execute supplier quality management program activities consisting of supplier monitoring, audits and issues resolution through supplier corrective action requests, operations NCRs and audit findings.
• Author supplier audit plans, perform audits and create audit reports and monitoring metrics, present at appropriate review meetings.
• Aid in complaint handling investigation, as requested.
• Ensure compliance to and promote awareness of quality management system and regulatory requirements. Support production in troubleshooting issues and improving yields.
• Work with contract manufacturers to resolve issues, close non-conforming material reports in a timely manner, and ensure compliance with internal procedures.
• Quality Engineering review of Document Change Orders and Supplier Change Notices.
• Ensure suppliers on the ASL are current and required documents are on file.
• Drive SCAR program to ensure suppliers complete and verify closure of implemented supplier actions.
• Determine quality improvement parameters for EBR and supplier’s manufacturing processes. Work with various departments to ensure timely closure of CAPAs, NCRs, and complaints. Work cross functionally to coordinate release and/or hold of materials that have been segregated as non-conforming. Document nonconformances, including root cause and corrections.
• Determine test method validation requirements, create test method validation protocols, and document testing.
• Participate as CAPA owner, performing thorough root cause investigation and documenting corrective and preventative action plans. Ensure action plans are implemented in a timely manner.
• Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost. Proactively solve moderately complex problems at the product level.
• Create and document appropriate test methods and accurately generate complex written reports which include establishing statistical confidence by identifying sample size and acceptable error rates. This includes testing for process validations, test method validation, and design verification and validation.
• Work with Contract Manufacturers to ensure compliance to requirements and product quality and lead the resolution of product quality issues remediations.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations. Adhere to established company Quality System procedures, the Quality Policy, and work instructions.

Other Duties and Responsibilities

• Maintain state of the art technical knowledge.
• Other duties as assigned

Education & Experience:

• BS in biomedical engineering or mechanical engineering
• Four years of related medical device experience
• Can be a combination of education and experience

Knowledge, Skills, & Abilities:

• Your understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR will enable you to properly audit and monitor suppliers.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
• Proficiency with statistical software, such as MiniTab, preferred.
• Ability to work independently, using good judgment, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
• Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
• Self-motivated and self-directed; conscientious approach to work assignments

Salary Range: $122,500 - $157,500

*Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.

 Disclaimer:  EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit car