To provide specific, yet flexible, Quality Engineering expertise in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance of existing operations.
Participate in and provide quality support in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices.
Lead and work with teams to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
Recommend, plan and lead corrective and preventive actions for continuous improvements including investigations and root cause analysis.
Generate quality reports, evaluate and trend quality data, and propose solutions to drive process improvements.
Drive and monitor change management process to ensure thorough completion of all changes resulting in timely closure of change requests.
Reviews and approves validation protocols, reports, and data related to software, equipment, process, and product validations.
Provide guidance in the proper application of statistical analysis and scientific design of all verification and validation test documentation.
Responsible for the Site Validation Master Plan.
Perform revalidation and risk assessments to support the site validation master plan.
Administrator of CAPA review board for the site.
Participate in or lead cross-functional project teams in identifying and executing programs/tactics to improve existing operations with respect to quality, cost, and delivery.
General Quality Support:
Facilitate risk management activities including creating and maintaining risk plans, reports, and failure mode analyses for multiple product lines.
Create, revise and approve documents as required by changes to policies or in response to compliance issues ensuring adherence to regulatory, regional and internal requirements.
Plan and execute internal audits at the site against applicable Quality System standards/regulations and internal requirements.
Review and approve nonconforming reports and CAPA plans
Bachelor’s degree or equivalent in science or engineering
Competency in Process Validation (IQ/OQ/PQ), Statistical Process Control and Capability Analysis
Work and problem-solve independently and as part of a team.
Excellent time management skills, work ethic and be proactive.
Excellent oral and written communication skills.
Must be able to write clear, concise and grammatically correct technical cGMP documents.
Proficient in Microsoft Office applications.
Strong understanding and application of the Quality System Regulations (QSR – CFR 820) and ISO 13485/ISO9001 requirements.
Minimum of 4 years of cGMP experience in the pharmaceutical or medical device industry.
Prior experience working in a Quality/Compliance, Validation, Engineering or technical role within the pharmaceutical or medical device industry.
Working knowledge of the requirements of FDA QSR CFR 820, ISO 13485 and ISO 9001.
Lean Manufacturing / Six Sigma experience preferable
About Bausch + Lomb
One of the oldest continually operating companies in the US today, Bausch + Lomb traces its roots to 1853, when John Jacob Bausch, a German immigrant, set up a tiny optical goods shop in Rochester, New York. When he needed more money to keep the business going, Bausch borrowed $60 from his good friend, Henry Lomb. Bausch promised that if the business grew, Lomb would be made a full partner. The business did grow and the partnership was formed.
In the early years, Bausch + Lomb manufactured revolutionary rubber eyeglass frames as well as a variety of optical products that required a high degree of manufacturing precision. By 1903, the firm had been issued patents for microscopes, binoculars, and even a camera shutter based on the eye’s reaction to light...
A History of Innovation
In the 1900’s, Bausch + Lomb continued to demonstrate its place at the forefront of technological innovation for optical products. Bausch + Lomb produced the first optical quality glass made in America, developed ground-breaking sunglasses for the military in World War I, and created the lenses used on the cameras that took the first satellite pictures of the moon. In 1971, Bausch + Lomb introduced t...he first soft contact lenses and is still the largest global provider of eye care products.
Although products and times have changed, Bausch + Lomb still adheres to the legacy of dedication to innovation, quality, and craftsmanship established by John Jacob Bausch and Henry Lomb. In August 2013, Bausch + Lomb became the eye care division of Bausch Health Companies Inc., formerly known as Valeant Pharmaceuticals International, Inc.