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About the Role
As the Supplier Quality Engineer, you will partner with cross-functional teams to execute critical Supplier Quality activities throughout the product development lifecycle, ensuring the highest quality standards and compliance with regulations. This hands-on role requires experience in supplier management, risk management, manufacturing line bring-ups, and design transfer, directly supporting the development of scalable quality systems.
Responsibilities
- Support the selection, evaluation, and monitoring of suppliers and assist in maintaining the Approved Supplier List (ASL).
- Work with suppliers and the Supplier Quality Manager to ensure quality agreements and technical expectations are met.
- Identify supplier risks and collaborate with cross-functional teams to prevent or resolve issues that could interrupt business continuity.
- Assist in maintaining procedures to ensure organizational compliance with applicable regulatory standards.
- Support suppliers and the technical team through key activities such as process FMEAs, manufacturing flow and control plans, master validation plans, process validation (IQ/OQ/PQ), and equipment qualifications.
- Work with Engineering and Operations teams to establish manufacturing test specifications, critical to quality specifications, and inspection criteria.
- Execute Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments, and Non-conformance Reports (NCRs).
- Participate and provide engineering input at Material Review Board (MRB) meetings.
- Track and report on defined KPIs and metrics for Supplier Quality.
- Support internal and external audits by coordinating and providing documentation and evidence of compliance.
- Foster a collaborative environment, support continuous improvement initiatives, and promote a quality culture across the organization.
Requirements
- Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, or related field).
- 3 – 7 years of quality engineering or medical device development experience from concept development to production release.
- Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1) and experience working in a regulated environment.
- Ability to travel up to 25% of the time.
- Prior experience in product / manufacturing line transfers.
- Hands-on experience with risk management tools (e.g. FMEA, risk analysis).
- Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking.
- Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment.
- Proficient in working in eQMS tools with impeccable documentation skills.
- Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies.
- Strong analytical skills and excellent problem-solving skills.
- Exceptional organizational skills and attention to detail.
Skills
- Supplier management
- Risk management
- Manufacturing line bring ups
- Design transfer
- Process FMEAs
- Manufacturing flow and control plans
- Master validation plans
- Process validation (IQ/OQ/PQ)
- Equipment qualifications
- Manufacturing test specifications
- Critical to quality specifications
- Inspection criteria
- Supplier Audits
- Supplier Qualifications
- Supplier Corrective Actions (SCARs)
- Supplier Change Assessments
- Non-conformance Reports (NCRs)
- Material Review Board (MRB)
- KPI and metrics tracking
- eQMS tools
- Documentation
- Written communication
- Verbal communication
- Analytical skills
- Problem-solving skills
- Organizational skills
- Attention to detail
Experience Level
- 3-7 years
Education Level
- Bachelor's degree in Engineering
- Master's degree in Engineering
Salary/Compensations
- $136,000—$170,000 USD
Benefits
- Competitive compensation
- Stock options
- Comprehensive benefits package
- 401(k) program with matching contributions
About the Company
- Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions.
- Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.
- Join a small, dedicated team of knowledgeable and motivated professionals.
- Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact.
- We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.
Equal Opportunity
- Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.