Sr. Quality Engineer
- Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
- Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
- Own or review Engineering Change Orders on assigned projects and product lines.
- Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives .
- Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
- Take the lead on risk analysis and documentation.
- Lead or participate in project teams - coordinating the quality efforts to meet project objectives.
- Plan, schedule, and execute engineering project work to meet business and quality objectives.
- Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
- Lead nonconforming report investigations and recommend appropriate corrective actions.
- Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
- Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data
- Provide leadership and mentoring to more junior staff. May supervise junior engineers.
- 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
- Advanced degree preferred
- Experience in auditing, design review, sterilization, project management, and/or product development is highly desired
- A passion for detailed analysis and problem solving.
- A knack for solving quality control problems effectively.
- The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
- 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.
- Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
- Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards
- Working knowledge of data collection, data analysis, and evaluation, and scientific methods.
- R&D or new product development experience helpful.
- ASQ CQE preferred.
- 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.
- Roseville, CA
- Starting Base Salary: $113,000/year - $157,000/year.
- Individual compensation will vary over time based on factors such as performance, skill level, competencies, and work location.
- 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).
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