Senior Supplier Quality Engineer

Description

We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits.

At Aerin Medical our values show up as: always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation and being all in.

As the Senior Supplier Quality Engineer, you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care.

PURPOSE OF JOB

This position is responsible for providing supplier quality engineering expertise to R&D, Operations, and contract manufacturer(s). He/She is the quality contact point for Aerin Medical suppliers. He/She is responsible for evaluating suppliers by conducting on site audits, analyzing defect trends, and leading continuous improvement projects. Responsibilities include identifying, investigating, and resolving supplier quality problems. Travel to the suppliers’ locations is a must.

MAJOR DUTIES AND RESPONSIBILITIES:

• Visit vendor facilities and observe the manufacturing and distribution environments to review and assess their processes and procedures
• Conduct supplier audits to ensure vendors continue to work in compliance with company and regulatory standards
• Review incoming supplies and finished goods from vendors to check for defects, ensure quality and authorize release
• Investigate and resolve supplier non-conformances, complaints and CAPAs leading to satisfactory closure
• Manage supplier management program, including establishment and maintenance of supplier file and monitoring of supplier performance
• Conduct tests and assessments on products to identify quality issues
• Maintain detailed reports on supplier quality, including defect rates and areas that
• result in flaws
• Provide technical advice and guidance to suppliers to reduce defect rates
• Conduct internal audits, as needed, and support external regulatory body audits
• Serve as a liaison between our company’s senior management and the vendors to identify quality issues and come up with solutions
• Evaluate product and process changes initiated by R&D, Operations, and/or contract manufacturers and assist with development of required documentation to support the changes
• Collaborate with Operations to monitor quality of production and review and authorize release of production Device Master Records and Lot History Records including sterilization records where applicable.
• Create and maintain company process FMEA. Review and maintain manufacturing process FMEA jointly with suppliers.
• Support management of Contract Manufacturer (CM) activities, including but not limited to monitoring contract manufacturer/supplier performance, enforcing applicable product & process quality requirement, and conducting routine supplier audits

Requirements

EDUCATION REQUIREMENTS:

• Bachelor’s degree in Engineering, Biomedical Engineering, Technical disciplineor equivalent is highly preferred

EXPERIENCE REQUIREMENTS:

• 5+ years of quality engineering experience and supplier management in medical device industry is required
• Good understanding of ISO 13485, EU MDR, FDA QSR Part 820, risk management (ISO 14971) and other applicable standards is required
• Certified Lead Auditor is required
• Prior experience in manufacturing environment, validation and sterilization is advantageous

OTHER QUALIFICATIONS:

• Excellent interpersonal and communication skills (both verbal and written) that allow for effective communication with all levels of organization
• Demonstrated ability to work well with cross-functional departments and
• stakeholders in a proactive and constructive manner
• Takes initiative and ownership to drive department and organization goals
• Fluent in Spanish is a big plus
• Travel will be required 6 times a year both domestically and internationally.

BENEFITS AND PERKS:

Our culture is rooted in our core values every day, in everything we do.

Our benefits focus on the 5 dimensions of wellbeing: physical, financial, emotional, career and community. Physical benefits include Medical – PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. Financial benefits include HSA/FSA, 401k with company match, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). Career and Learning & Development opportunities with Aerin led leadership trainings. Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving.