Quality Engineer

Similar Industry Experience in a Food, Pharma or Dietary Supplement Manufacturing Industry is preferred for this PositionPosition Summary:Responsible for the day-to-day quality engineering activities as well as maintenance and enhancement of the company's quality management system. Also supports adherence to regulatory and company requirements and is responsible for supporting the operations to improve business performance through support of key quality initiatives.Essential Duties and Responsibilities:To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Develop and maintain quality risk management files for products and processes. -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.Assist with training and risk management activities FSMA 21 CFR 117, ISO 14971, HACCP, HARPC, pFMEA, etc.Supplier Quality Management (Vendor Qualification) includes scorecard creation and upkeep.Finished product formula and raw material/packaging component specification compliance review.Responsible for internal compliance auditing the day-to-day quality operations, including the environmental monitoring and measurement device metrology calibration records, sustaining the QA technicians and Lab Technicians in the manufacturing and laboratory operations.FDA and other regulatory documentation updates including develop protocol, execute/report cleaning/manufacturing processes/software/methods validations, development, facilities and equipment suitability and qualifications (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.Reviews government regulations and facilities modifications and implementation of procedures as necessary.Assist with development and review of documents related to regulatory compliance, e.g. change control review board.Drafts and/or facilitates the development of standard operation procedures and participates or supports efforts to perform regular audits to ensure compliance.Support quality auditing (including internal QMS and supplier quality), assist with supplier development/review/approval qualification questionnaires, review and approval of Batch Production Records, nonconforming material OOS trend reports.Coordinate CAPA investigations, effectiveness reviews, and trending.Implementing methods to inspect, test, and evaluate the reliability of manufacturing processes, products, and production equipment.Support and coordinate improvement efforts and priorities with other departments to ensure timely release of the raw material, packaging components and finished products.Coordinate with manufacturing and other personnel to discuss and resolve quality issues as required.Create necessary documentation for out-of-house processing.Support complaint management including internal investigations, root cause analysis, and trending.Responsible for the preparation and maintenance of quality metrics to provide status updates as well as identification of key problem areas.Write product and process deviations when necessaryParticipate in site Continuous Improvement activities.Review product labeling for content, appearance and regulatory compliance.Identify statistical techniques and sampling plans required for establishing, controlling, and verifying process capability and product characteristics.Support pest control activities and ensure they are monitored and followed up upon.Develop a team-oriented process to attain department and company objectives.Performs other related responsibilities as assigned by Quality and Regulatory leadership.Competencies:To perform the job successfully, an individual should demonstrate the following:Continuous Learning - Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.Innovation - Displays original thinking and creativity. Meets challenges with resourcefulness. Generates suggestions for improving work. Develops innovative approaches and ideas.Planning and Organization - Integrates changes smoothly. Plans for additional resources. Prioritizes and plans work activities. Sets goals and objectives. Uses time efficiently. Works in an organized manner.Problem Solving - Develops alternative solutions. Gathers and analyzes information skillfully. Identifies problems in a timely manner. Resolves problems in early stages. Works well in group problem solving situations.Use of Technology - Demonstrates required skills. Adapts to new technologies. Troubleshoots technological problems. Uses technology to increase productivity. Keeps technical skills up to date.Qualifications:Education/Experience -Bachelor of Science in engineering or science degree preferred; chemistry, biology, or related discipline is required. Equivalent strong analytical, technical, manufacturing operations experience; quality experience in a regulated manufacturing environment; minimum of 1 year previous practical work experience in food, pharma and/or dietary supplements manufacturing preferred.Excellent interpersonal skills and ability to work effectively in a team environment.Good organizational skills and ability to manage job duties.Ability to work independently and problem-solve.Must have knowledge of Regulatory Compliance - FDA, cGMP, GLP, and other GxP regulatory requirements pertinent to dietary supplements, or applicable regulated manufacturing and laboratory testing methodology.Strong preference for regulated life science industry experience, including FDA, TGA, MHRA, ISO 17025"”especially dietary supplement manufacturing.Language Ability - Read, analyze and interpret business, professional, technical or governmental documents. Write reports, business correspondence and procedure manuals. Effectively present information and respond to questions from managers, customers and the public.Mathematical Ability - Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Compute rate, ratio and percent, and draw and interpret bar graphs. Ability to perform complex mathematical operations, such as decay rates, molarity calculations, and interpret raw data and present it in a meaningful way to aid in the product development process.Reasoning Ability - Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Computer Skills - Working knowledge of statistical software such as Minitab is a plus. Intermediate Knowledge of Microsoft Office Suite, Internet Explorer and email.Certificates and Licenses - None required. CQE or CQA Certification from ASQ or SQA highly preferred.Supervisory Responsibilities:This job has no supervisory responsibilities.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually moderate.Work environment involves moderate risks or discomforts which require special safety precautions, e.g., working around moving machines in production facilities, handling of hazardous testing and sanitation chemicals. Protective clothing or gear such as goggles, gloves and shoes may be required. Aerosolized product powder levels may occur during sample preparation.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must regularly lift and /or move up to 25 pounds, occasionally lift and/or move up to 50 pounds with assistance. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus.Work also requires some physical strain such as long periods of standing and walking in production facility and lifting of moderately heavy items such as test equipment kits and product cases. Other physical demands include climbing, crouching, and reaching.The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.Job Type: Full-timePay: From $65,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programHealth insuranceLife insurancePaid time offVision insuranceSchedule:8 hour shiftMonday to FridayWeekends as neededWork Location: In person

Created: 2025-03-01