Supplier Quality Engineer
Western DigitalSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical DevicesIndustries
Requirements
- Bachelor’s degree in engineering or scientific discipline
- 5+ years of engineering experience, preferably in a medical device environment (or equivalent combination of education and experience, and/or demonstrated performance)
- Demonstrated experience in Supplier Quality Engineering, Supplier Engineering, Manufacturing or Quality Engineering, R&D, or other related technical roles
- Ability to travel up to 10%
- In-depth knowledge of QSR, ISO, and other applicable regulations and standards
- Training and experience in performing supplier audits (plus)
- ASQ CQE certification (plus)
- Experience with Electronics and PCBAs (plus)
- A passion for detailed analysis and problem solving
- Strong project management skills and a proactive drive to plan and execute projects that align with business needs
- The desire to be part of a great team and to represent Supplier Quality Engineering on cross-functional technical teams
- The ability to lead with humility, a collaborative mindset, and confidence
- Strong oral, written, and interpersonal communication skills
- The ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing
- Versatility, flexibility, and a willingness to work within changing priorities
Responsibilities
- Provide technical and quality support for IQC in solving day-to-day quality issues; identify and lead Supplier or IQC improvements and drive projects
- Lead Supplier Second Source Qualifications (SSQs) and Supplier Changes (SCs) to closure, including performing technical assessment; work with suppliers and internal cross-functional teams to identify and mitigate risks
- Lead or participate in project teams representing Supplier Quality Engineering, coordinating supplier quality efforts to meet project objectives
- Drive closure of Supplier Corrective Actions (SCARs) and support root cause analysis and corrective action implementation with the supplier
- Align supplier inspection/testing programs with Penumbra’s methodologies
- Investigate supplier-related failures (e.g., IQC NCRs) and drive short and long-term resolution with suppliers and internal teams
- Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards
- Lead the qualification and development of new or current suppliers
- Design experiments and tests, and apply statistical rationale to analyze and interpret engineering test data
- Lead in the management of the Approved Supplier List
- Mentor junior Supplier Quality Engineer(s) in support of Supplier Quality Engineering responsibilities
- Lead the development, monitoring, and analysis of supplier performance metrics; identify trends and risks and independently take appropriate actions
- Identify and lead continuous improvement efforts related to supplier quality compliance or QMS
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the starting base salary for the Senior Supplier Quality Engineer position?
The starting base salary ranges from $119,000 to $166,000 annually.
Is this role remote or does it require office presence?
This information is not specified in the job description.
What are the key qualifications and experience required for this role?
Candidates need a Bachelor’s degree in engineering or scientific discipline with 5+ years of engineering experience, preferably in medical devices, and demonstrated experience in Supplier Quality Engineering or related technical roles. In-depth knowledge of QSR, ISO, and other regulations is also required.
Does this role involve travel?
The role requires the ability to travel up to 10%.
What experience makes a candidate stand out for this position?
Strong candidates will have 5+ years in Supplier Quality Engineering or related fields in a medical device environment, experience leading supplier qualifications, SCARs, and cross-functional projects, plus knowledge of QSR and ISO regulations.
Penumbra Inc
Develops medical devices for vascular conditions
About Penumbra Inc
Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.
Alameda, CaliforniaHeadquarters
2004Year Founded
$116.7KTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees