Sr. Quality Systems/CAPA Engineer

Abbott Laboratories • Pleasanton, CA

8d • $90,000 - $180,000

About The Position

The Senior Quality Systems Engineer assures products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success. The position employs an individual skilled in advance quality assurance techniques with an in-depth understanding of the ISO 13485 Quality Standard and US 21 CFR 820 QSR. Areas of focus will include improving quality system infrastructure, performance metrics and ISO, FDA and GMP compliance.

Requirements

• Bachelor’s degree in engineering or Technical Field
• Minimum 5 or more years of Engineering experience and demonstrated use of Quality tools/methodologies
• knowledge of FDA820, GMP, ISO 13485, and ISO 14971

Nice To Haves

• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues
• Internal and External Audit experience
• MS or higher degree in a technical discipline
• Advanced computer skills, including statistical/data analysis and report writing skills
• medical device industry experience
• ASQ CQE or CQA certification

Responsibilities

• Assure compliance with corporate and divisional requirements regarding metrics reporting for the Management Controls / Management Review and CAPA quality systems.
• Assure the collection, compiling, reporting and dissemination of key quality and compliance metrics/data are completed within the requiring timing.
• Complete trend analysis of data as appropriate to ensure proper actions can be determined or assessed.
• Perform and assure timely follow-up activities in support of key quality and compliance metric/data goals and policy/procedural requirements.
• Develop and provide data and analysis in support of Management Controls / Management Review and CAPA Quality Systems.
• Identify and implement opportunities for continuous improvement.
• Identify opportunities to apply, continuously improve, and redefine quality systems and controls product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Represent Quality Systems as required in support of cross-functional projects.
• Assist in company preparations for hosting external audits.
• Participate in external and internal audits.
• Assists management teams to ensure timely closure of audit observations.
• Lead non-conformance investigation teams to identify root causes and effective CAPAs.
• Lead, coach, and mentor non-exempt and entry level exempt personnel on quality principles and procedures.
• Function as part of risk assessment teams to identify product, quality system and compliance requirements.
• Function as part of special project teams to identify compliance gaps and develop and execute strategies to close gaps.

Benefits

• Employees can qualify for 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