Strong fit for candidates with deep medical device quality engineering experience who thrive in cross-functional, fast-paced environments and can manage supplier risk and compliance.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Echo Neurotechnologies via Greenhouse
Company Overview
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.
Team Culture
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.
Position Overview:
As the Supplier Quality Manager, you will partner with the cross-functional team to act as a champion of Supplier Quality activities throughout the product development lifecycle. You hold your work and teams to the highest quality standards and ensure all applicable compliance standards and regulations are met. This is a hands-on role requiring deep experience in supplier management, risk management, and manufacturing line bring ups and design transfer. As a Supplier Quality Manager, you will be building scalable quality systems while directly executing critical quality engineering activities across multiple programs.
Primary Duties & Responsibilities:
Lead selection, evaluation and monitoring of suppliers and maintain the Approved Supplier List (ASL)
Collaborate with suppliers to establish quality agreements and technical expectations
Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity
Create and/or maintain procedures to ensure that the organization complies with applicable regulatory standards
Guide and 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), equipment qualifications
Work with the Engineering and Operations teams to identify manufacturing test specifications, critical to quality specifications, and inspection criteria
Oversee and manage the execution of Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments, Non-conformance Reports (NCRs)
Participate in decision-making at Material Review Board (MRB) meetings
Define KPIs and metrics for Supplier Quality and create/define systems to support the efficient collection and analysis of data for such KPIs and metrics
Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance
Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization
Qualifications:
Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, or related field).
10+ years of quality engineering or in medical device development 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
Skills and Abilities:
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
Salary$180,000—$210,000 USDWhat We Offer
An opportunity to work on exciting, cutting-edge projects to transform patients’ lives in a highly collaborative work environment.
Competitive compensation, including stock options.
Comprehensive benefits package.
401(k) program with matching contributions.
Equal Opportunity Employer
Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.
Confidentiality
All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.