Quality Engineer in Millersburg, PA at Apex Life Sciences

Date Posted: 6/3/2018

Job Snapshot

Job Description


Key Responsibilities: 
 

  • Collect, analyze and present quality data.
  • Establish and optimize test methods and product specifications.
  • Write and conduct validations (IQ/OQ/PQ) for manufacturing processes and equipment.
  • Analyze adequacy of inspection criteria and techniques, recognize critical attributes when establishing validation requirements.
  • Develop and write protocols for new procedures.
  • Review and edit existing procedures.
  • Work with Product Development/Engineering to implement new processes and products.

Minimum Requirements/Qualifications: 
 

  • Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
  • Ability to understand various manufacturing processes.
  • Excellent writing and communication skills.
  • Ability to interface well with others working at all levels.
  • Ability to develop and implement procedures.
  • Ability to perform investigative process as well as critical thinking and problem solving.
  • Knowledge of statistical based computer programs such as Minitab, as well as Microsoft Office.
  • Ability to read and understand CAD drawings.
  • Experience working in a cGMP environment.
  • Experience working in a manufacturing environment

Non-Negotiable Hiring Criteria: 
 

  • Bachelor's degree in engineering or science related field.
  • 2+ years of quality or engineering experience.
  • Ability to understand various manufacturing processes including plastics manufacturing.
  • Excellent technical skills.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.