Quality Engineer II

The Quality Engineer II has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.

The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.

Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may lead the investigation/corrective action process.
 

Responsible for day-to-day QM Engineering responsibilities for product and related operational areas. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives.

REQUIREMENTS

Bachelor's degree. Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field.

2+ years experience in Quality, Quality Control, or Supplier Quality.

PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS

Experience with independently writing and executing validation protocols

Experience in a medical device or pharmaceutical manufacturing facility.

Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485

Clinical Diagnostic experience a plus

Ability and skill to effectively manage multiple tasks and drive execution of change management plans

Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
Six sigma, additionally root cause analysis and project management techniques are routinely employed

Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience

Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations

Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems