Quality Assurance Specialist

4 weeks ago


Bethlehem, Pennsylvania, United States ABEC Full time

Job Summary:

The Quality Engineer will play a key role in implementing company-wide operations procedures and processes to support the overall Quality Assurance plan. This role will assist in Quality improvement throughout the shop floor and within the team concept, participating as a cross-functional team member within assigned goal-oriented team responsibility.

Key Responsibilities:

  • Support and maintain ABEC Quality program.
  • Maintain and ensure compliance to ABEC SOP's.
  • Support and maintain ABEC quality practices and guidelines.
  • Participate in internal and vendor audits as directed.
  • Participate in FAT, IQ/OQ activities as assigned.
  • Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions).
  • Coordinate assigned Continuous improvement initiatives.
  • Review, approve and administer Engineering Change/Release Notices (ECN's).
  • Complete Document Control and Change Management assignments as directed.
  • Maintain documents in ABEC archives.
  • Support new product development activities as directed.
  • Execute other tasks as assigned (Quality, Project, Product Development, etc.).
  • Follow all safety rules and policies.
  • Execute other tasks as assigned.
  • Ability to travel when required.

Requirements:

  • Bachelor's Degree in Engineering required (Chemical, Mechanical or Electrical Engineering preferred).
  • 3-5 years post graduate work in a quality field.
  • Experience with cGMP or ISO 0, Six Sigma, CQE.
  • Candidates must possess strong interpersonal and problem-solving skills.
  • Excellent communication skills, both written and verbal.
  • Detail oriented and ability to prioritize.
  • Good at multitasking.
  • Proficiency in Microsoft Office: specifically, Outlook, Word, and Excel.
  • Awareness of and prior experience with implementing Continuous Improvement (CI) a plus.
  • Prior Lean/Six Sigma experience a plus.


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