Quality Engineer I

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Purpose of Job:

Supports the development and maintenance of the site quality systems to assure compliance with applicable regulatory requirements, standards and B+L QMS requirements.

Manage and / or perform all hands-on tasks of the quality assurance function / quality unit.  These include but are not limited to QA support of daily warehouse operations and facilities, including nonconformance resolution, site projects, site validation oversight/support and process improvements.

Key Activities:

Implement, maintain and support quality management systems necessary for cGMP and Good Distribution Practices compliance.

Quality oversight of warehouse and distribution activities to ensure FDA, other applicable regulatory requirements and standards and Bausch + Lomb Quality Management System compliance.

Support Quality Management System initiatives.

Support the investigation and approve or reject deviations regarding equipment, products, shipments, temperature monitoring.

Implementation and /or oversight of the corrective action / preventive action program.

Support/coordinate validation activities (review and approve validation protocols, reports and data)

Implement/support change control process and risk management.

Capable of identifying systemic weaknesses and leads initiatives to implement applicable corrective measures.

Perform/support audits to ensure on-going compliance.

Assist with product quality release process as required – e. g. QA review, release, hold, rejection and/or quarantine of product returns.

Create metrics, analyze data and present metrics/trends including proposed solutions with action plans to management.

Coordinates or leads activities of the various functional areas whenever a critical quality or compliance issue is discovered. Keeps management updated on compliance issues that occur and proposes solutions with action plans.

Other duties as assigned.

Qualifications:

Bachelor’s degree in engineering or science in a scientific or technical discipline is preferred or a minimum of 5-6 years of experience in applicable quality related functions in an FDA/GMP environment/regulated facility. Years can be combined between Pharma, Medical Devices and Food industries preferably working directly with various elements of the Quality Management System.

Distribution/Logistics experience is a plus

Certifications are desirable (eg CQA, CQE)

Audit experience is a plus

Excellent communication skills (verbal and written).

Ability to work independently

Strong compliance audit, attention to detail, analytical and computer skills.

Ability to successfully influence others/drive activities regarding quality, compliance and timeliness.

Ability to hold people and functions accountable for product release timeliness.

Demonstrated expertise in implementing and maintaining quality management systems compliance preferably associated to quality engineering improvement projects.

 This position may be available in the following location(s): US - Woodruff, SC (Distrib)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.