hirly
Sign inGet started free

Penumbrainc

Sr Quality Engineer

Alameda, CA

See how you match this job — and similar ones. Free.

Upload your resume and hirly scores it against this role at Penumbrainc first, then against similar open jobs, and shows where you fit and why.

PDF or DOCX, up to 12MB. No sign-up to see your matches.

Get past the screening software and onto a recruiter's desk

hirly rewrites your resume for this job — matching the keywords and skills in the posting, moving your most relevant experience to the top, and writing a cover letter to fit. About 30 seconds.

  • Keywords matched to this posting
  • Fit score before you apply
  • Cover letter included
Tailor my resume for this job →

Apply from your AI assistant

Connect hirly to Claude and ask it to apply to this job. hirly tailors your resume, fills the employer’s form and asks before sending. ChatGPT: manual setup today.

See how it works

Some employer sites stop an application at a CAPTCHA or sign-in and hand it back with a link. Applying needs a paid plan. Works with any assistant that supports MCP.

hirly's read of this role

Seniority
Senior
Stated salary
$125,000 – $175,000 per year
Country
US
Work mode
On-site / unstated
First seen by hirly
3 Sept 2026

Derived automatically from the posting. Upload your resume above to see how the role scores against it.

the posting

  • General Summary
  • The Senior Quality Engineer role is for a fully qualified engineer in all conventional aspects and functional areas. 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. Monitor design control and provide quality assurance support. 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.
  • Specific Duties and Responsibilities
  • Participate in the development and qualification activities for new and existing products.*
  • Lead and participate in project teams coordinating the quality efforts to design, 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. *
  • Perform engineering work including one or more of the following:
  • Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
  • Develop and validate measurement methods
  • Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards
  • Support developmental projects in the area of quality assurance
  • Analyze reports and returned products and recommend corrective and preventive action
  • Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
  • Participate in NCR or CAPA board as necessary
  • Assist in and perform QSR training. *
  • 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.
  • Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *
  • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
  • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
  • Ensure other members of the department follow the QMS, 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 or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience, preferably in a medical device or regulated industry environment
  • Additional qualifications:
  • Advanced degree preferred
  • Experience with Process Failure Mode and Effects Analysis (PFMEA), sustaining projects, commercial medical device manufacturing, Non-Conformance Reports (NCRs), Failure Investigations, and Change Control
  • Experience in auditing, design review, sterilization, project management, and/or product development highly desired
  • Experience with Contract Manufactured Medical device products
  • 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.
  • Must be able to move between buildings and floors.
  • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
  • Must be able to read, prepare emails, and produce documents and spreadsheets.
  • Must be able to move within the office and access file cabinets or supplies, as needed.
  • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
  • Location and Pay
  • Alameda, CA
  • $125,000 to $175,000
  • We offer a competitive compensation package plus a benefits and equity program, when applicable.
  • Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Original posting on Penumbrainc's site ↗

Listed on hirly, a job board. hirly is not the employer: Penumbrainc is hiring for this role.

Similar jobs

Want this one?

Upload your resume and hirly rewrites it for this job and writes the cover letter — in about thirty seconds, before you sign up.

Tailor my resume for this job