Quality Engineer

Position Description: The quality engineer supports the Quality Department in ensuring projects are produced within required specifications, quality/regulatory compliance, continuous improvement, trend analysis, and variation reduction to paperwork, processes, product, and people (training).

Essential responsibilities:

•    Quality risk management

o    Principles of quality risk management, General quality risk management process Responsibilities Initiating a quality risk management process, Risk assessment, Risk control, Risk communication, Risk review, Risk management methodology, Integration of quality risk management into industry and regulatory operations. 

•    Supplier Quality Management (Vendor Qualification) 

•    TGA and other regulatory documentation updates including develop protocol, execute/report processes, methods, facilities validations and equipment IQ/OQ/PQ.   

•    Support Product Quality Reviews and data for quality metrics.

•    Review raw material and finished product specification documentation and support MRB disposition decisions.

•    Assist with training and risk management activities FSMA 21 CFR 117, ISO 14971, HACCP, HARPC, pFMEA, etc. 

•    Assist with development and review of documents related to regulatory compliance, e.g. change control review board.  

•    Support quality auditing (including supplier quality) and assist with supplier development/review/approval qualification questionnaires, review and approval of Batch Production Records, NCMR, and CAPA investigations.

•    Support and coordinate improvement efforts and priorities with other departments to ensure timely release of the raw material, packaging components and finished products.

•    Create necessary documentation for out-of-house processing.

•    Support complaint management including internal investigations and root cause investigations. 

•    Continuous Improvement Experience a plus.  

•    Ability to review product labels for content, appearance and regulatory compliance. 

•    Other responsibilities as assigned Quality Assurance and Regulatory department management.

•    Track, trend, and report key performance indicators (KPIs) and metrics.

•    Manage the training system to ensure employee training is current and effective.

•    Perform quality investigations related to deviations and customer complaints.

•    Lead CAPA projects and other process improvement efforts

•    Support cleaning and process validations.

•    Perform internal audits and documentation of discrepancies.

•    Communicate with production and customer service departments to ensure that projects are completed and documented.

•    Write and review SOPs.

•    Supervise document and process change control.

•    Ensuring all employees follow cGMP requirements within the facility.

•    Other duties as assigned by supervisor.

Additional Responsibilities:

•    Adhere strictly to company policies and procedures.

Education Requirements:

•    Scientific degree or equivalent strong analytical experience. 

•    Knowledge and experience in GDP, cGMP, & GLP.

•    Understanding of cGMP 21 CFR 111, 21 CFR 117, GLP, and other regulatory requirements pertinent to dietary supplements, or applicable regulated (device/pharmaceutical) manufacturing and laboratory testing methodology.

•    Strong preference to experience in TGA or MHRA auditing and submission processes. 

Competencies/skill Qualifications:

•    Attention to detail and accuracy.

•    Excellent interpersonal and listening skills.

•    Strong verbal and written communication skill.

•    Data analysis and problem solving.

•    Adaptability and initiative.

•    Knowledge of GMPs and experience with nutraceuticals a plus.

•    Must demonstrate exceptional written and communication skills.

•    Ability to follow instructions / directions.

•    Ability to work well under pressure in a fast-paced environment.

•    Attention to details.

•    Ability to prioritize and complete assigned tasks effectively and efficiently.

•    Able to make decisions based on company guidelines.  Exceptional organizational, multi-tasking and time-management skills are required.

•    Ability to adapt to a dynamic environment and maintain effectiveness during times of major changes in responsibilities

•     Demonstrate integrity and willingness to take personal responsibility for performance.

•    Auditing experience preferred but not required.

•    Experience enforcing SOP and product specifications preferred.

•    Proficiency with all MS Office Suite programs – Word and Excel experience required. 

•    Strong mathematics skills required.      

•    English proficiency required.

Physical Requirements:

•    While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; converse and listen; taste or smell.

•    Employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force constantly to move objects.

•    Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

•    May be exposed to a dusty environment (including known food allergens) and/or considerable noise