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.
We are seeking an experienced, high caliber Quality Engineer – II (Device/Combination Product). Responsible for ensuring the requirements for Device/Combination Products through the execution of Abbott standard operating procedure and Design Control Lifecycle Management . Reports to Staff Quality Engineer for the Cardiac Rhythm Management business unit.
- Provide Quality Support for Device-Drug Combination Product by reviewing and approving design control and risk management activities.
- Review and approve analytical test methods and stability activity documents to meet the standard operating procedure and compliance requirements for all products.
- Work closely and effectively with multiple functions (R&D, Operations, Regulatory Affairs and/or supply chain etc.,) to ensure design control expectations are met.
- Participate and represent as combination product quality assurance subject matter expert during internal, cross site and external regulatory agency inspections.
- Follow design control standard operating procedures and ensure all requirements are met .
- Identify and trouble shoot design verification tasks as part of design control activities.
- Bachelor's degree required; typically, in Sciences, engineering or other technical scientific area.
- 3-6 years' experience in Quality Engineering or Manufacturing Quality, Development Quality or Pharmaceutical Product Development or other related field
- Analytical Chemistry and Device regulation (design control) experience is preferred.
- Knowledge of regulations and standards affecting devices and pharmaceutical products
- Knowledge of US and EU regulations, and ISO standards.
- Strong written and verbal communication skills
- Strong interpersonal skills at all levels within the organization
- High level of organizational skills and independence
- Working knowledge of quality systems for Device/Combination product design and engineering experience is a plus
- Performs other related duties and responsibilities, on occasion, as assigned.
- Previous device-drug combination product quality assurance or engineering experience
- Prior medical device experience preferred
- Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), CFR Part 4, CFR Part 210/211, along with GMP, and ISO standards
- Solid communication and interpersonal skills, strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- ASQ CQE, CQA certification preferred