General Overview
If you're passionate about quality in the medical device sector, consider joining Penumbra as a Senior Supplier Quality Engineer. In this pivotal role, you will be instrumental in ensuring a strong and compliant supply chain that guarantees the highest quality standards for our innovative products. Collaborating closely with diverse teams, you will tackle supplier quality issues and initiate improvements related to performance, quality, capacity, and cost management. Your leadership will be essential for resolving quality challenges and spearheading critical initiatives like supplier qualifications and risk assessment efforts.
Key Responsibilities
- Provide expert technical and quality support for IQC in addressing daily quality challenges and lead supplier improvement projects.
- Oversee Supplier Second Source Qualifications (SSQs) and Supplier Changes (SCs), ensuring thorough technical assessments and effective risk mitigation strategies.
- Actively participate in project teams representing Supplier Quality Engineering, ensuring alignment with project objectives.
- Drive the resolution of Supplier Corrective Actions (SCARs) and collaborate on root cause analyses and corrective actions with suppliers.
- Establish and align supplier inspection and testing programs with Penumbra's quality methodologies.
- Investigate supplier-related failures and facilitate short- and long-term solutions in partnership with suppliers and internal teams.
- Collaborate with suppliers to enhance technical processes, reliability, and quality controls to meet or exceed Penumbra's standards.
- Lead the qualification and development initiatives for both new and existing suppliers.
- Design experiments and tests, applying statistical principles to analyze and interpret engineering test data.
- Manage and oversee the Approved Supplier List.
- Mentor junior Supplier Quality Engineers to support their professional growth and development.
- Develop, monitor, and analyze supplier performance metrics to identify trends and risks, acting independently on findings.
- Lead and drive continuous improvement projects related to supplier quality compliance or QMS enhancements.
Starting Base Salary : $119,000 to $166,000 annually
Position Requirements
A Bachelor's degree in engineering or a scientific field with a minimum of 5 years of relevant experience, ideally within the medical device industry.Proven experience in Supplier Quality Engineering, Manufacturing, R&D, or related technical roles.Willingness to travel up to 25% of the time.Additional Qualifications
In-depth knowledge of QSR, ISO, and pertinent regulations and standards.Experience in conducting supplier audits is advantageous.ASQ CQE certification is considered a plus.Familiarity with Electronics and PCBAs is beneficial.Strong analytical and problem-solving abilities with a passion for attention to detail.Effective project management skills with a proactive approach to aligning projects with business objectives.A collaborative mindset, combined with the ability to lead with humility and confidence.Excellent oral, written, and interpersonal communication skills, capable of presenting complex issues in a clear manner.Adaptability and a willingness to navigate changing priorities smoothly.What We Offer
Join a dynamic and collaborative team where continuous learning and performance recognition are integral to our success. Be part of a mission-driven organization dedicated to revolutionizing treatment for some of the world’s most challenging health conditions. We offer a competitive benefits package including medical, dental, vision, life insurance, AD&D, short and long-term disability insurance, a 401(k) plan with employer match, an employee stock purchase program, paid parental leave, and generous vacation and sick leave policies.
Penumbra, Inc. is headquartered in Alameda, California, and is committed to innovative healthcare solutions. Our products are designed for hospitals and healthcare providers, ensuring we meet significant healthcare needs worldwide.
Penumbra is an equal opportunity employer. We embrace diversity and encourage applications from all qualified individuals without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by law.