Valeant Pharmaceuticals

Engineer, Quality II

US-FL-Clearwater
Job ID
8753
Pos. Category
Operations
Pos. Type
Full Time

Overview

The Quality Engineer II 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.

 

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.

 

This role supervises direct reports. 

Responsibilities

  • 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. Develops validation strategy/Quality plans for projects.  Guides team on proper components of IQ/OQ/PQ/PV activities.
  • 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.
  • Supports manufacturing in improvement of processes, cost/waste reduction projects, resolution of nonconformances, maintenance/ improvement of quality system.  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.
  • 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.
  • Evaluate proposed changes for design control requirements. Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria. 
  • Write validation protocols, perform or manage performance of protocols, analyse data and write validation reports (as assigned).
  • 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.
  • Supervises complaint investigators and oversee the complaint investigation process. Interacts with Global Product Surveillance and other functions to investigate and as appropriate initiate corrective actions for complaints.
  • Support company goals and objectives, policies and procedures, quality systems, and FDA regulations.

Key Relationships:

Internal: Functional representatives within Bausch + Lomb facilities.

External: Suppliers, external auditors/regulatory authorities, and customers.

Qualifications

Required Education: Bachelor’s Degree BS in engineering or Technical Field or equivalent


Required Experience: 3-6 years Quality experience, minimum 3 years’ experience in Medical Device and/or Pharmaceutical Industry.

 

Preferred Experience:

  • Knowledgeable of ISO 9001/ISO 13485 and FDA/QSR requirements and quality system development and management.
  • Knowledgeable of other regulations desired.
  • Knowledgeable of statistical techniques and application experience.
  • 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.
  • Training and experience in validation, auditing, statistics (DOE, SPC) 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.)
  • Certified ASQ CQE and/or Lean Six Sigma Green belt preferred. 

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

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 Valeant’s Job Offer Fraud Statement.

 

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