Full-Time

Senior Manufacturing Quality Engineer

Bausch Lomb

Bausch Lomb

No salary listed

No H1B Sponsorship

Greenville, SC, USA

In Person

Bachelor's

Category
QA & Testing (1)
Required Skills
Six Sigma
ISO 9001
Data Analysis
Requirements
  • A four-year college degree (Bachelor of Arts or Bachelor of Science) in life sciences, physical sciences, or engineering is required.
  • At least 5 years of quality experience, including a minimum of 3 years in medical device or pharmaceutical manufacturing, is required.
  • Working knowledge of 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 9001, quality tools, problem-solving tools, and statistical analysis is required.
  • Experience leading, conducting, and writing investigations is required.
  • Strong verbal and written communication skills and the ability to manage multiple priorities are required.
  • Applicants must be authorized to work for any employer in the United States; employment visa sponsorship or takeover of sponsorship is unavailable.
Responsibilities
  • Ensure that new products are properly integrated into the existing quality system.
  • Lead efforts with manufacturing and engineering to develop plans for continual improvement of product and process quality.
  • Ensure that decisions are based on sound quality principles and regulatory guidelines.
  • Support and lead investigations and corrective action efforts.
  • Promote the use of statistical analysis to determine improvements and provide analyses to support risk mitigation.
  • Evaluate complaint trends to drive improvements and assist in investigations as necessary.
  • Independently lead failure investigations using root cause analysis tools and propose and implement systemic corrective actions.
  • Use Lean and Six Sigma tools to identify areas of improvement, particularly related to process controls, and use relevant statistical tools to analyze data for proactive improvements.
  • Provide routine analysis of performance indicators and present this information to management, supervisors, and manufacturing operators.
  • Guide engineering and manufacturing personnel in establishing appropriate qualification and validation criteria.
Desired Qualifications
  • Certification as a Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager is preferred.
  • Experience in aseptic manufacturing or parenteral product manufacturing in a current Good Manufacturing Practice environment is preferred.

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