Job Description

Position Title: Quality Engineer (Commercial)

Department:Quality Assurance

Reports To:Quality Engineering Supervisor

FLSA:Exempt

Grade:C2

Date:January 23, 2015

Purpose and Scope

The Quality Engineer supports Quality Assurance by directly interacting with internal customers to ensure the quality of marketed products and compliance with FDA and foreign regulatory requirements as well as TOLMAR Inc. quality expectations.

Essential Duties & Responsibilities

  • Develops a variety of quality reports and provide tracking and trending data for proactive resolutions and evaluation of product performance per established regulations and within schedule.
  • Responsible to develop Annual Product Reports (APR) in a timely matter and in compliance with regulatory requirements for contents, trends, and approvals.
  • Responsible for procedures and compliance related to APRs, Investigations, yield calculations, and Failure Modes and Effects Analyses (FMEAs).
  • Compiles and evaluates data for Quality Management Review presentations.
  • Participates in decision making process regarding product quality issues.
  • Provides guidance and statistical evaluation to interpret analytical data associated with product release, stability reports, validation activities, laboratory investigations and manufacturing investigations to support TOLMAR Inc. release and compliance decisions.
  • Assist with and conduct investigations, including determination of root cause, identification of corrective and preventive actions (CAPA) and establishing/measuring CAPA effectiveness. This assistance is for all company investigations with emphasis on:
  • Manufacturing/Packaging investigations
  • Laboratory investigations
  • Validation investigations
  • Supports manufacturing and packaging process improvement initiatives.
  • Provides statistical support and DOE for internal investigations,validations and any Quality System continuous improvement action plan.
  • Defines, identifies and applies product and process control methods such as developing control plans and identifying critical control points for sampling/inspection.
  • Acts as a QA representative on project teams to define critical points and classify product defects.
  • Interact with investigators/ auditors during regulatory inspections and marketing partner audits.
  • Performs various other duties as assigned.

Knowledge, Skills & Abilities

  • Proficient knowledge with MS Office and statistical software packages.
  • Excellent verbal and written communication skills demonstrated through interactions internally and externally.
  • Effective organization and project management skills.
  • Effectivetroubleshooting and problem solving skills.
  • Ability to work both independently and in conjunction with a team.
  • Ability to develop working relationships with both internal and external customers.

Education& Experience

  • Bachelor’s degree in Chemistry, Engineering, Biology or other related field.
  • 5 or more years of Quality Engineering/Quality Assurance experience in a pharmaceutical, medical device or manufacturing industry.
  • CQE/CQ preferred.

Working Conditions

  • Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work.
  • Occasional work inside manufacturing clean rooms where gowning is required.

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