Associate Director, QA Project Management

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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with 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.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

Reporting to the Global Quality Post Market Director this role will lead the initiation, planning and execution of projects and ensure technical feasibility, resource availability and allocation. Develop plan to monitor and track progress, coordinating with internal and external parties for the flawless execution of assigned projects.

The role will provide strategic direction and recommendations for technological solutions to support overall Complaint Handling and Investigation processes.

Interacts with management to reach agreement regarding significant program strategies. Present strategies and updates to management and stakeholders. Assure that projects will effectively integrate with existing programs and strategies so that long- and short-term business goals are attained. Recognize the broader implications of actions and proposals on the final project outcome, related systems and activities, and general business strategy.

Manages multiple projects with moderate complexity. Complies with quality system. Defines the nature of the stated business or technical problem. Develop project specifications and objectives, strategies, timelines and milestones/design and development plan. Utilize project scheduling software to plan and track projects.

Interface with other functions, internal clients, and project staff and internal/ external experts as required. Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues.

What You'll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Coordinate input from multiple areas or multiple functional managers on related projects. Identify resource requirements, cost, and time schedules. Develop an implementation plan, conduct risk assessments and develop contingency plans to accommodate unforeseen events.

• Lead cross-functional teams through project planning exercises to develop detailed schedules and integrated annual improvement plan.

• Assist management in selecting the specific action plans that will best meet the identified long-term business issues. Anticipate long-term future problems, resolve current issues, learn and adjust based on prior results and prior project leadership experience.

• Prepare and present project progress reports to keep management and team informed. Identify problems, their resolution, trends, and their impact on project success; propose recommendations for management action.

• Interacts frequently with internal and external management concerning projects, operational decisions, scheduling requirements and prioritization clarification.

• Negotiate project outcomes and deliverables to meet the conflicting demands of time, money and deadlines. Maintain project expenses within budget. May function as the project contact with third party vendors.

• Accountable for the total project scope; completion of project tasks under direct or matrix control within scheduled completion date.

• Formulate long term strategic objectives and implements project plans, ensures milestones are met and prioritizes as required to meet commitments.

• Establish relationships with business partners to develop strategies that incorporate value, risks, operational impacts (ROI) and cost of proposed solutions with focus on increase productivity and improve compliance

• Drive cross-functional teams to meet milestones and deliverables, established in project planning and agreed upon with senior leadership.

• Prepare and presents written and other presentations to internal and external audiences. Adjusts presentation style and content to suit the audience.

• Champions and actively participates in development / improvements of complaint handling processes and procedures.

• Work effectively with Customer Service and R&D, as well as other internal and external organizations as needed, to coordinate and facilitate improvements in complaint handling processes.

• Facilitate meetings and discussions across multiple organizations as required to improve/enhance complaint handling processes.

• Interacts with management to escalate compliant issues as identified.

Required Qualifications

Bachelors degree in a related field or an equivalent combination of education and work experience

Minimum of 7 years of Quality experience in medical devices or pharmaceutical regulated environment managing/leading organizations.

Substantial knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971.

Must have solid project management skills, team leadership skills and proven executive stakeholder management skills.

Preferred Qualifications

Minimum of 2 years of Complaint Handling Experience

Lean Six Sigma Certification, or equivalent is desired.

PMP certification is a plus.

Considered a Subject Matter Expert and key contributor to initiatives.

Leader and key contributor to initiatives and advancement of the Quality organization.

Emerging Leader.

Demonstrates strong leadership competencies.

Wide application of technical principles, practices, and procedures.

Strong understanding of business unit function and cross group dependencies/relationships.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Has a sound knowledge of various technical alternatives and their impact.

Apply Now

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $144,100.00 - $288,300.00. In specific locations, the pay range may vary from the range posted.