General Summary
This role is for a Senior Quality Engineer supporting commercial manufacturing of interventional medical devices. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for manufacturing. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.
What You'll Work On
• Provide support to Operations and Commercial product manufacturing by providing input, support, review and Quality approval for processes such as (but not limited to) Engineering Change Orders, Incoming/In-process/Final Inspections, Equipment Support, Second Source Qualifications, Supplier Changes, SCARs, Deviation Authorizations, Non-Conformance Reports and Control Chart investigations.
• Lead and participate in project teams coordinating the quality efforts to develop and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes.
• Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements.
• Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
• Develop and validate measurement methods
• Support developmental projects in the area of Quality Assurance and Quality Engineering
• Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
• Support NCRs and CAPAs as necessary
• Support activities during FDA inspections, FDB inspections, and notified body audits.
• Participate in the development of standard operating procedures.
• Prepare documentation for inspection/testing procedures.
• Perform responsibilities required by the Quality System and other duties as assigned.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
•Participate and support Quarterly Reviews as needed
• Assist in and perform QSR training.
• Perform other work-related duties as assigned.
What You Bring
• Minimum education and experience:
• Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Engineering (QE) and ISO, or an equivalent combination of education and experience
Additional qualifications:
• QE Production and/or Operations support experience preferred
Location and Salary:
• Alameda, CA
• Starting Base Salary is $126,310.00 - $163,160.00
• Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location, and shift.
Working Conditions
• General office, laboratory, and cleanroom environments.
• Business travel from 0% - 10%
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.
• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment 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 federal, state, or local laws.
