Quality Engineer within the Quality Department, communicating problems, situations, opportunities, and progress to Quality Manager.  Responsible for Validation programs and Change Control Process.  Assists in all GMP audits for compliance with internal and customer requirements.

Primary Responsibilities

  • Lead validation activities, capability studies, review and analysis of validation test results, and revalidation assessment of validated systems.
  • Establish master validation plan, equipment and process reviews, develop qualification test plans and protocols.
  • Develop, run and analyze data for DOEs related to product development or project teams.
  • Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
  • Create and update a variety of correspondences and memos.  Gather data to create complex reports including charts, graphs, tables and spreadsheets for review and approval.
  • Perform and report audits of internal departments as required.
  • Participate in supplier audits as required.
  • Assist in investigation of quality complaints and out of specification events. Monitor any corrective actions that result from investigations.
  • Attend internal and customer meetings to communicate questions, concerns, and updates with processes and products as needed.
  • Represent the company in a positive and professional manner during regular customer and vendor site visits.
  • Perform other duties as assigned.

Language Skills:

  • Ability to read, understand, and interpret FDA regulations and ISO standards.
  • Ability to read, analyze and interpret batch records, audit records and letters.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, customer auditors, and members of the business community.
  • Ability to factually document events and findings.
  • Ability to effectively present information to top management and corporate representatives.

Computer Skills:

  • Knowledge of Microsoft Office (to include PowerPoint, Word, Excel, Access and Project)
  • Minitab

Other Required Skills and Abilities:

  • Knowledge of Good Manufacturing Practices, ISO 13485, 21CFR Parts 10, 11, and 820, IQ/OQ/PQ.
  • Excellent interpersonal, presentation, and business communication skills.
  • Detail oriented
  • Quick learner and creative problem solving skills.
  • Excellent organizational skills.
  • Ability to react quickly to unexpected occurrences.
  • Requires positivity, initiative, and self-motivation.
  • Ability to work independently with minimum supervision.

Licenses, Certifications, Registrations:

  • CQE, CQA, Six Sigma and/or Lean Certifications preferred.
  • Willingness to attend applicable skill building and training seminars and events as requested.

Physical Demands:

Working conditions are normal for a manufacturing environment and an employee must be able to successfully perform these functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to regularly sit, talk, hear, stand, walk, and use hands and arms to manipulate, handle, reach and feel. Work may involve lifting of materials and product up to 40 pounds. The noise level in the office and the packaging floor is low to moderate, respectively.

Education Requirements:

Bachelor’s Degree in Engineering and 2+ year experience in an FDA regulated Medical Device or Pharmaceutical manufacturing quality department is preferred.

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