Senior Quality Assurance Engineer
Job Summary
Job Description
As a Senior Quality Assurance Engineer at Penumbra, you will play a crucial role in the quality system and operations support to ensure the highest quality in products and compliance with regulations. You will analyze complex challenges, drive solutions, communicate quality objectives, mentor junior team members, and promote a culture of quality. Key responsibilities include serving as a subject matter expert, owning quality systems, supporting qualification and validation, acting as a technical problem-solver, participating in cross-functional teams, designing experiments, partnering with suppliers, leading investigations for Nonconforming Reports (NCRs), identifying and implementing Corrective Action Preventative Actions (CAPA), reviewing Engineering Change Orders (ECOs), and supporting audits.
Must have:
- Bachelor's degree in engineering, life science, or related field
- 5+ years of relevant experience
- Experience in Quality Assurance
- Experience with ISO
- Strong oral, written, and interpersonal communication skills
- High degree of accuracy and attention to detail
- Proficiency with Microsoft Word, Excel, PowerPoint
Good to have:
- Experience in auditing
- Experience in sterilization
- Experience in environmental controls
- Experience in operations
- Experience in project management
Perks:
- Collaborative teamwork environment
- Opportunity to revolutionize treatment of devastating diseases
- Generous benefits package
- Medical, dental, vision, life, AD&D insurance
- Short and long-term disability insurance
- 401(k) with employer match
- Employee stock purchase plan
- Paid parental leave
- Eleven paid company holidays
- Fifteen days of accrued vacation per year
- Paid sick time
7 skills required
Job Details
General Summary
As a Senior Quality Assurance Engineer at Penumbra, you will have an important role in many aspects of the quality system and operations support to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis and problem solving to analyze complex challenges and drive effective solutions. You will be looked to for communicating quality objectives, mentoring junior team members, driving continuously improvement, and promoting Penumbra’s culture of quality throughout the organization.
Specific Duties and Responsibilities
•Serve as a subject matter expert on key areas of the Quality System (e.g. sterilization, environmental controls, inspection, & testing).*
•Own and lead one or more quality systems, driving continuous improvement and ensuring compliance with internal standards and regulatory requirements.*
•Mentor and lead junior engineers, providing technical guidance and professional development. May supervise junior engineers.*
•Support or lead qualification and validation activities for products, equipment, and facilities, ensuring readiness for production and compliance with standards.*
•Act as a technical problem-solver, proposing and implementing robust solutions to complex quality and engineering challenges.*
•Lead or participate in cross-functional project teams - coordinating the quality efforts to meet project objectives.
•Plan, schedule, and execute engineering project work to meet business and quality objectives.
•Design experiments and tests, and apply statistics to analyze and interpret engineering test data
•Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
•Lead Nonconforming Report (NCR) investigations and identify appropriate corrective actions.
•Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
•Continuously assess and improve internal controls and system documentation to support regulatory compliance and operational excellence.*
•Own or review Engineering Change Orders (ECOs) on assigned projects and areas of responsibility.
•Support FDA, FDB, and notified body audits and inspections*
•Act as a liaison with internal departments, customers, and suppliers on quality-related matters.*
•Provide training and guidance to peers and staff on quality regulations, best practices, and QMS requirements.*
•Ensure full compliance with the Quality Management System (QMS) and applicable domestic and international regulations, standards, and procedures.*
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Position Qualifications
Minimum education and experience:
•Bachelor's degree in engineering, a life science, or related field with 5+ years of relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience
Additional qualifications:
•Strong oral, written and interpersonal communication skills
•High degree of accuracy and attention to detail
•Proficiency with Microsoft Word, Excel, PowerPoint and other standard office tools
•Experience in auditing, sterilization, environmental controls, operations, and/or project management is highly desired
Location and Salary:
Alameda, CA
Starting Base Salary: $113,000/year - $157,000/year
Working Conditions
•General office, laboratory, and cleanroom environments.
•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.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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