Quality & Regulatory Compliance Engineer

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.

Point-of-care diagnostics is a growing and dynamic industry helping to improve clinical and economic outcomes globally. Abbott brings a variety of expert viewpoints on new innovations, insights, and impacts that are shaping the future of diagnostics around the world.

Abbott Rapid Dx North America, LLC’s Orlando site i s part of Global Business Services (GBS) within the Abbott Rapid Diagnostics (ARDx) Division.

GBS has a global accountability to deliver an excellent customer experience and create business value through compliance, standardization and data analytics.

GBS also designs and develops Software products for ARDx businesses. The GBS group fosters a collaborative, team focused and winning environment where employees are accountable and encouraged to develop themselves.

The Quality and Regulatory Compliance Engineer is responsible for ensuring compliance and continuous improvement for business processes relating to Field Corrective Actions and Quality Holds, Computer System Validation (CSV) and Risk Management.

RESPONSIBILITIES :

• Comply with Quality System SOPs and Work Instructions and suggest modifications to ensure on-going process compliance and efficiencies.
• Execute continuous improvement projects, as defined by the leadership team, that are critical to the business or improve the general compliance of site processes.
• Oversee the Computer System Validation program, ensuring all applicable software systems, spreadsheets, and other required items remain in a validated state and applicable processes are created and maintained.
• Supports audits and regulatory inspections (i.e. FDA, ISO, Divisional audits).
• Oversee inventory quality holds and Field Correction Action (FCA) activities managed by the site at the direction of Abbott and Third-Party Legal Manufacturers.
• Support the Risk Management program, ensuring Risk Management Plans for applicable processes are created and maintained.
• Perform quality processes including change control, non-conformance and Corrective and Preventive Action (CAPA).
• Other duties as assigned.

Education & Experience

• Bachelor’s Degree in a technical or life science field, or an equivalent combination of education and work experience is required.
• 2 years’ experience in a quality and / or regulatory function required.
• Knowledge of FDA regulations and ISO standards applicable to the medical device industry required.
• Experience with CAPA and Root Cause Analysis required.
• Must have strong organizational, interpersonal, written and verbal communication skills with a strong attention to detail.
• Must be self-directed, adept at juggling multiple projects and comfortable in a fast-paced and ever-changing work environment.
• Experience with internal and / or external audit program.
• ISO lead auditor certification or equivalent is preferred.
• SAP Experience preferred.
• Must be proficient in MS Outlook, Word, Excel and data reporting, trending and analysis.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

The base pay for this position is $57,300.00 $114,700.00. In specific locations, the pay range may vary from the range posted.