Capa Engineer Ii Jobs

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 115,000 colleagues serve people in more than 160 countries.

About Abbott

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with lifechanging 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.

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

The Opportunity

Responsible for facilitating and executing to the CAPA process.

Pay

The salary range for this position is 65,200K - 130,400K based on experience.

What You'll Work On

• Contribute to continuous improvement initiatives and projects.
• Provide support and subject matter expertise during audits and inspections.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Execute and provide on-time completion of Quality Assurance engineering deliverables.
• Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.
• Independently investigate, gathers data, and perform preliminary analysis.
• Lead meetings and communications for CAPA updates, information, and concerns.
• Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
• Support team in the delivery and oversight of CAPA training program.
• Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
• Assist in the initiation, processing and completion of CAPA records in the electronic system.
• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
• Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.

Required Qualifications

• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Bachelor's Degree preferably in the engineering, healthcare, or science fields or an equivalent combination of education and work experience, a Master's Degree preferred.
• Strong organizational and follow-up skills, as well as attention to detail.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Ability to travel approximately 5%, including internationally.
• Solid communication and interpersonal skills.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• ASQ CQT, CQE, CQA certification preferred.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Six Sigma root cause analysis/problem solving training and experience preferred.
• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Prior medical device experience preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Minimum 2 years significant engineering and/or technical operational experience plus demonstrated competence.
• Ability to leverage and/or engage others to accomplish projects.

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 salary for this role is between $65,200 – $130,400