Supplier Quality Engineer

Job Description

Job Description

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure , a chronic, progressive condition in which the heart is unable to pump enough blood to support the body.

Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure.

These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs.

With our recent PMA approval from the FDA, we are preparing to grow our team it’s a great time to join Endotronix!

WHAT YOU’LL DO

The Supplier Quality Engineer is responsible for overseeing the supplier management program at Endotronix, in compliance with applicable Quality procedures.

They have a strong understanding of Quality Management System (QMS) fundamentals and help to maintain and strengthen Endotronix’s existing culture of quality.

This individual is a subject matter expert on the supplier module of the e-QMS software (Grand Avenue), supplier evaluations, investigations and corrective actions associated with supplier-related quality issues, and the recurring activities (such as audits and scorecards) required to maintain control of suppliers in a regulated industry.

• Act as a liaison between Endotronix and our suppliers, in the area of quality
• Maintain and update the supplier audit system and schedule
• Conduct on-site, virtual, and / or desktop supplier audits to drive process standardization, waste elimination, and continuous improvement
• Establish specific short- and long-term supplier quality goals
• Support problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non-conformances
• Partner with Endotronix product quality engineers to investigate and resolve supplier-related technical issues in a timely manner to ensure continuity of supply
• Maintain supplier performance metrics and scorecards
• Develop long-term supplier relationships
• Partner with Engineering, Operations, and R&D in the evaluation and qualification of new suppliers, following the Endotronix supplier management process and applicable standards and regulations
• Strategically lead supplier performance improvement projects to increase supplier capabilities
• Assist with management and monitoring of key performance indicators (KPIs) related to supplier quality
• Coordinate timely completion of supplier evaluations and supplier control activity records in the Grand Avenue Supplier Module (or applicable e-QMS system)
• Comply with internal and external quality requirements for supplier management
• Model a culture of quality within the organization

WHAT YOU BRING TO THE TABLE

The ideal Supplier Quality Engineer candidate has :

• 2+ years of experience in supplier quality management in the medical device industry or another regulated industry
• A strong working knowledge of ISO 13485, 21 CFR 820, and / or EU MDR 2017 / 745 requirements relevant to suppliers
• Quality Auditor Certification (ISO 13485 Lead Auditor, ASQ-certified CQA, or similar)
• Experience working within e-QMS software, such as Grand Avenue
• Excellent written and oral communication skills, including the ability to clearly and logically explain rationale for decisions
• Excellent interpersonal skills, with the ability to negotiate and influence others
• Proficiency in Microsoft and Google products (Word, Excel, PowerPoint, Gmail, Docs, Sheets)
• Demonstrated critical thinking and problem-solving skills
• Strong working knowledge of various quality system methodologies, such as 5-why analysis, pareto analysis, Six Sigma, etc.
• Integrity and understanding of the importance of following documented procedures
• Reliability in following through on commitments and meeting agreed upon timelines, with the ability to independently manage their own time and projects
• Strong organizational skills with attention to detail
• Demonstrated experience creating reports, generating, interpreting, and presenting metrics
• Passion for continuous learning and improvement

EDUCATION

Bachelor’s degree in engineering or related discipline

WHO YOU ARE

• Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
• Someone with a bias for action and quick iteration as opposed to perfection
• A quick learner, who is able to work independently, multitask, and drive your own projects
• An effective communicator and collatorator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights models and tools that provide easily interpretable and actionable results
• A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
• Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale

WHAT WE’RE LIKE

• Willing to have the direct and honest conversation . Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
• Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
• Entrepreneurial, flexible, yet results focused.
• High degree of intellectual curiosity, honesty, and capability.
• Low ego and humble in spirit in spite of your track record of outstanding performance.

LIFE AT ENDOTRONIX

Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability.

Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors.

This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.

This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination.

Executive, management and supervisory levels have the responsibility to further the implementation of this policy and ensure conformance by subordinates