Job Summary - a concise overview of the job
The Quality Engineer is responsible for collaborating with other quality, engineering, and manufacturing operations functions to ensure the quality aspects of validation and qualification activities, performing various types of analysis and generating and reviewing internal investigations, CAPAs, and change controls. Typically involved with more complex projects. Collaborates with other departments to implement improvements and ensure quality standards are in place. Authors/revises department SOPs.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Typically works with a single site and has no monetary budget authority
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Validation & Qualification
§ Typically involved with more complex projects related to process validation, packaging validation, computer validation, IQ, OQ and PQ
§ Reviews and may approve the generation and maintenance of validation/qualification protocols
§ Uses quality engineering tools to support investigations, corrective actions, continuous improvement projects, and process capability improvements (FMEA, root cause analysis, process mapping, Six Sigma, SPC, DOE, etc.)
§ Performs statistical analysis for the identification of trends
§ Generates or reviews change controls, SOPs, CAPAs, investigation etc. to ensure compliance with cGMPs
§ Reviews and may approve engineering or document change controls
§ Collaborates with other departments to implement improvements and ensure quality standards are in place
§ Authors/revises department SOPs that reflect current practices and are in compliance with FDA and other regulatory requirements and guidance
§ Tabulates defined department /site metrics and reports to departmental management
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ BS in Engineering, Science, or equivalent and a minimum of 3+ years of relevant experience
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Ability to handle more complex projects, including process validation, packaging validation, IQ, OQ and PQ
§ Ability to display and analyze data in a logical manner
§ Good communication skills, including reading and understanding technical instructions
§ Good attention to detail
§ Solid organizational skills
§ Ability to take initiative, set priorities and follow through on assignments
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Ability to stand for up to 8 hours
§ Ability to wear personal protective equipment, including respirators, gloves, etc.
§ Manual dexterity
§ Ability to lift and carry 15 lbs.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as requir