Quality Engineer III

Penumbra Inc. • Alameda, CA

64d • $109,000 - $152,000 • Onsite

About The Position

You will have an opportunity to identify and own high impact projects to life saving medical devices. In this opportunity, you will independently support Commercial Operations to ensure the high-quality manufacturing of Class II/III interventional medical devices. This position will provide work with problems of advanced scope where the analysis of situation or data requires a review of identifiable factors. Work with collaborative teams to exercise good judgment to determine appropriate quality actions, and communicate and implement quality objectives.

Requirements

• Associate's or Bachelor's degree in Engineering, a Life Science or a related field with 3+ years of quality engineering or relevant experience, preferably in a medical devices environment, or equivalent combination of education and experience
• Familiarity with QSR, ISO, and other applicable regulations and laws required
• Excellent verbal, written, and interpersonal communication skills required
• Proficiency with MS Word, Excel, and PowerPoint required

Nice To Haves

• Leadership skills desired

Responsibilities

• Support Commercial Operations and Manufacturing activities such as Incoming/In-process/Final Inspections, NCRs, CAPAs, Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and Equipment sustaining activities.
• Support assigned manufacturing product lines and perform failure analyses and defect investigations as appropriate.
• Execute and collaborate on Continuous Improvement efforts.
• Execute and support supplier activities such as Second Source Qualifications, Supplier Changes, and SCARs.
• Interface with other engineering departments within the company, and suppliers on quality related issues.
• Collaborate and/or help lead in the development of manufacturing documentation.
• Design, improve and support Test Methods, Testing Equipment and TMVs.
• Recommend revisions to specifications, acceptance criteria, and manufacturing documentation to improve quality of product and/or Manufacturing Operations.
• Provide guidance to junior Quality Engineers in support of departmental functions.
• Perform responsibilities required by the Quality System and other duties as assigned or requested.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees