Easter Seals Jobs

Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of its Quality System.

• Support the Non-conformance, CAPA, validation and risk management systems to ensure the following:

• Relevant procedures and requirements are considered and applied

• Timely completion of support activities

• Assist teams with investigation methodologies and validation strategies

• Author non-conformance reports.

• Coordinate investigation activities cross-functionally.

• Ensure timely non-conformance processing.

• Assist teams with notes, action item recording and follow through, and communication to senior leaders as needed.

• Participate in technical review discussion as a QA representative.

• Coach engineering and support teams on QA tools and processes.

• Serve as a Quality representative for disposition and decision-making.

• Communicate complex information both verbally and in writing.

• Participate in root cause investigations.

• Document notes, record and follow-up on action items, and communication to senior leaders as needed.

  Qualifications:

  Training and Education

• Required – bachelor’s degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.

• Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.

• ASQ Certification (e.g., Certified Six Sigma Green Belt, CQE) a plus.

  Experience

• Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.

• Previous experience in an Engineering, Scientific or Investigative role is preferred.

• Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.

• Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) a plus .

• Familiarity with electromechanical and pneumatic components and systems is a plus.

  Knowledge, Skills and Abilities:

• Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)

• Technical writing skills

• Writing procedures, flowcharting

• Ability to collaborate cross-functionally

• Application of Quality Risk Management principles

• Attention to detail (e.g., document reviews, investigation write ups).

• High level of written and verbal communications skills

• Ability to communicate with Statisticians and perform statistical calculations as instructed

• Wisdom to seek help when needed.

• Proficiency in MS Office tools, including Outlook, Word, and Excel

  Physical Requirements:

• Must be able to lift at least 25 lbs. and may be required to lift up to 50 lbs.

• Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.