Abbott Principal Quality Engineer in Santa Clara, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Primary Job Function:
Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
General - Develops local strategy which is aligned with the business strategy and implements related tactical activities. Translates strategic needs of the division into executable long-range programs and projects. Provide solutions to a wide range of difficult problems.
Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders. Directly influences project direction and scope.
Interacts effectively with employees; manager; and cross-functional peers. Excels in effective and positive communications. Contributes functional skills and expertise broadly. Scope includes one or more QA functions with general knowledge of other related disciplines.
Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
Quality System Compliance - Demonstrates complete understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to Division and Corporate policies and procedures. Implements and maintains effectiveness of ADD's Quality System; including the Subsystems and Key processes that govern the area by identifying compliance risks.
Risk Management - Defines the business results expected from risk management strategies and projects.
Leads ADD (Abbott Diagnostics Division) in determining the changes; improvements; and investments needed to support the Risk Management process in the Quality System and business driven objectives. Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
Reviews and approves Risk management documentation.
Complaint Evaluation - Investigates complex complaints and carries out tasks with management guidance. Provides overall direction. Ensures compliant documentation in cross-functional areas of support.
Design Control / Documentation & Change Control - Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy. Acts as Process Owner and represents the site as an SME or Process Community Member. Negotiates complex changes. Identifies key processes that may be impacted as a result of the change. Effectively reviews and discusses changes with key stakeholders.
Quality Engineering - Draws conclusions reflecting broad business and quality needs. Champions new initiatives and acts as the catalyst for change within and potentially across divisions. Negotiates complex quality decisions. Participates as SME in audits. Acts as a consultant at site and Division or in partnership with supplier for developing quality related strategies for major projects.
Validation - Acts as site SME in audits for all aspects of validation (minimum 2 subsections). Acts as a consultant at site and Division or in partnership with supplier for developing validation strategies for major projects.
Travel: usually less than 5%, but on occasion, up to 10%.
Receives little detailed or general direction. Responsible for ensuring compliant documentation in cross- functional areas of support. Carries out tasks with management guidance; typically, is responsible for decision making. Decisions have long term impact; aligned with the organization strategy.
Bachelor’s Degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
At least 8 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree. Has experience in the medical device or in-vitro device industry.
Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
5(+) years' experience with Design Controls and working closely with Design Assurance activities for New Products in accordance with design planning procedures, including but not limited to:
21 CFR 820, ISO 13485,IVMDD (In Vitro Medical Device Directive), Document Control Systems (e.g. APLM)
Review and approval of verification protocols and reports
Review of verification plan(s)
Review of system and design documentation
Chairing meetings to review and approve action plans for addressing test defects
Performing Risk Management tasks where applicable related to Design requirements, test protocols, configuration management, and documentation, and participate in Technical Reviews to ensure design plans and deliverables related to product development are met.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com