The role of Quality Engineering is integral to the on-going compliance of the manufacturing processes. The Senior Quality Engineer is responsible for ensuring compliance of our products and processes throughout the product lifecycle, including development, manufacturing, and post-market in medical device regulated environment.
• Product design: ensures verification and validation requirements are adequately addressed, ensures that new products are seamlessly integrated into the existing quality system. Develops validation strategy/Quality plans for projects. Guides team on proper components of IQ/OQ/PQ/PV activities.
• Key participant in the design transfer process. Guides project team in development of design/process verification/validation plans. Evaluates current Quality System, and determines how new products will fit within system. Determines if any changes are required.
• Leads teams to develop/update risk management files & PFMEAs for new processes and process changes. Focus team on implementing capable processes, process controls, and error-proofing measures.
• Manufacturing support: Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
• Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness, and leads initiatives to implement corrective action.
• Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.) and identifies trends. Presents this information to management, supervisors, and manufacturing operators. Leads initiatives to improve performance.
• Post-launch maintenance: Evaluate proposed changes for design control requirements. Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria.
• Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls. Uses relevant statistical tools to analyze data for proactive improvements. Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
• Evaluates complaint trends and drives improvements. Investigates individual complaints.
• The Quality Engineer must be self-directed, and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives, and driving continual improvement in the Quality System.
• Writes validation protocols, perform or manage performance of protocols, analyse data and write validation reports (as assigned).
• Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria.
• Provide daily support to managers/staff regarding Document Change Requests and the Document Control System.
• Maintains electronic information including training, documents, scanning, deviations, DCRs and DCOs.
• Support company goals and objectives, policies and procedures, quality systems, and FDA regulations.
• The Quality Engineer must possess excellent written and verbal communication skills, and be able to guide others to make sound Quality decisions.
Primarily supports Clearwater, Surgical and Vision Care Quality. May be requested to support other Bausch & Lomb facilities as needed. The position will also include routine interaction and communications with internal business stakeholders and external business partners.
Bachelor’s Degree BS in engineering or Technical Field or equivalent.
6-8 years Quality experience, minimum 3 years’ experience in Medical Device and/or Pharmaceutical Industry.
• Knowledgeable of ISO 9001/ISO 13485 and FDA/QSR requirements and quality system development and management.
• Knowledgeable of other regulations desired.
• Use of statistical techniques and application experience.
• Training and experience in validation, auditing, statistics (ex. DOE, SPC).
• Strong written and oral communication and interpersonal skills.
• Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills.
• Working knowledge of FDA regulations and experience with managing external agency audits necessary.
• Certified ASQ CQE and/or Lean Six Sigma Green belt preferred.
• Training in problem solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis)
• Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles.)