Abbott Manager Design Quality Engineering in Liberty, South Carolina

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

JOB DUTIES:

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are collaborative, dynamic and progressive. We value people with new ideas who partner with others both internally and externally to take action and accomplish goals.

We are actively seeking an extraordinary Development Quality Manager to be responsible for development quality engineering function, supporting Product development projects (PDP) and continuous engineering programs. Specifically, providing oversight of the teams regarding project planning, design input and design output requirements, Risk Management, Design verification and Validation activities as well as partnering with operations quality to ensure precise transfer to manufacturing for our EP systems.

Are you ready to make a difference?

IMPACT THIS ROLE WILL HAVE ON ABBOTT:

  • Partner with research and development to help drive the design control process and ensure timely market authorization.

  • You will actively lead and develop engineers and technicians through review and planning, training, performance management and feedback to meet the overall needs of the business.

  • Analyzes projects for resource requirements, and ensure resource availability to all projects. Assigns and reviews project work of staff, sets work priorities, and reviews work.

  • Prepares overall project quality plans including achievements, validation processes and documentation procedures.

  • Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.

  • Responsible for budgeting/cost control, space and equipment acquisition, problem resolution, communication and policy implementation.

  • Guide and support design assurance engineers during design control and risk management processes to ensure conformance to applicable standards and compliance with applicable laws and regulations. Ensure risk management is properly implemented and followed throughout the product lifecycle

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Support continuous improvement through ownership and implementation of CAPAs as they relate to risk management and design control

  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and runs the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Follows U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

  • Performs other related duties and responsibilities, on occasion, as assigned.

QUALIFICATIONS:

  • A Bachelor's degree in an applicable engineering discipline with ten (10) plus years of progressively more responsible work experience in quality assurance and design related to medical devices, preferably in electro-mechanical Capital Equipment and Software

  • Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality assurance design methodologies and project management tools.

  • Five years or more in quality or R&D engineering management.

  • Knowledge of Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13 Knowledge of Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13485, ISO 14971), as well as other applicable standards including IEC 60601-1 and IEC 62304.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

  • Ability to work effectively within a team in a dynamic changing environment.

  • Multi-tasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.

  • Class III or II medical device experience

It has been and will continue to be the policy of Abbott to be an equal opportunity employer. In keeping with this policy, Abbott will continue to recruit, hire, train and promote into all job levels based solely upon job-related qualifications without regard to race, color, religion, creed, age, sex, national origin, gender identity or expression, sexual orientation, disability, marital status, veteran or military status, genetics or citizenship status.

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 corpjat@abbott.com