Staff Development Quality Engineer

Abbott Laboratories • Pleasanton, CA

6d • $114,000 - $228,000

About The Position

Independently or lead a project team of supervisors/engineers/technicians, to support Design/ Development Quality. Identify, plan and conduct projects requiring a combination of conventional and custom risk-managed execution plans as well as design controls deliverables, manages multiple often concurrent projects.

Requirements

• Bachelor’s Degree.
• Minimum 9 years of related work experience with a complete understanding of specified functional area.
• Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
• Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Nice To Haves

• Master’s Degree

Responsibilities

• Provide technical and quality system guidance related to establishing design controls requirements.
• Development of strategy and leading execution of deliverables for the team or organization and coaching/ mentoring on technical skill on the subject matter.
• Supports design verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, review and approval of protocols and reports, review of development plans, and review of other system and software documentation.
• Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
• Performs risk evaluation and associated management activities related to product development including FMEA, product risk analysis, and mitigation of failure modes.
• SME for statistical techniques and can provide cross-functional support to develop, update additional sampling and analysis activities as well as test of comparison.
• Participates in technical and management reviews to ensure design plans, product design and deliverables related to product development are met. Represent the quality engineering function for the review and approval of designated design outputs.
• Supports process validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
• May be involved with supporting product software development activities in conjunction with a cross-functional team
• Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
• Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
• Maintains a strong, collaborative partnership with cross functional team members especially with R&D.
• Works as an individual contributor and may provide guidance or oversee work of other QE team members.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior