Quality Assurance/Regulatory Compliance Engineer

2 weeks ago

Lebanon, United States Permobil Full time

Responsible for the direct support of manufacturing operations on the shop floor; ensures quality and consistency of products by establishing product inspection criteria and methods; monitoring internal product quality; working with appropriate parties to improve product quality; and analyzing and reporting on quality data.


PROVIDES QUALITY SUPPORT TO OPERATIONS BY:

Investigating non-conforming material and determining its disposition; determining characteristics critical to quality and safety based on product drawings, risk management documentation and feedback from appropriate departments; determining acceptance criteria and inspection methods and frequency for raw goods, components, and finished products; assessing the impact of uncalibrated or out of tolerance measuring equipment; and utilizing appropriate standards for determination of sample size and frequency.Investigates customer complaints and analyzes complaint trends to determine if corrective actions are required.


IDENTIFIES AND MITIGATES RISK BY:

Understanding how requirements laid out in ISO 14971 and government regulations for risk management apply to company products and processes; supporting formal risk management activities as a member of the risk team; and utilizing risk management tools such as FMEA, Hazard Traceability Matrix, Fault Tree Analysis, and Root Cause Analysis.


SUPPORTS IMPROVEMENTS By:

Managing and analyzing data for products; tracking the impact of product and process changes on product quality; participating in Lean and Six Sigma activities, Kaizen events, and other improvement initiatives; presenting reports to appropriate department managers; and providing feedback to leadership.


SUPPORTS REGULATORY COMPLIANCE BY:

Identifying and educating others on regulations and standards applicable to the product and manufacturing process; evaluating processes, change requests, and deviations against regulatory requirements; and supporting internal and external audits.


TAKES FULL QUALITY OWNERSHIP BY:

Monitoring and reporting on Production Line quality including but not limited to quality of components, quality performance of products manufactured on production lines; Coordinating improvements with operations supervision; communicating external supplier nonconformities to Group Supply Chain for resolution; and managing quality of internal suppliers. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables. Solid understanding of statistical techniques.


Requirements:

Bachelor’s degree in Engineering or Scientific discipline is strongly preferred

2 + years related experience.

Ability to use independent judgement with minimal guidance to achieve objectives of assignments, operating within specific policy and department guidelines.

Professional certification may complement a non-Engineering degree.

Familiarity with medical device regulations – 21 CFR Part 820 and ISO 13485 preferred.

  • Quality Assurance/Regulatory Compliance Engineer

    2 weeks ago

    Lebanon, United States Permobil Full time

    Responsible for the direct support of manufacturing operations on the shop floor; ensures quality and consistency of products by establishing product inspection criteria and methods; monitoring internal product quality; working with appropriate parties to improve product quality; and analyzing and reporting on quality data.PROVIDES QUALITY SUPPORT TO...

  • Quality Assurance Team Leader

    2 weeks ago

    Lebanon, United States Ken's Foods Full time

    Great opportunity with growing company! Ken's Foods in Lebanon, IN is looking for a Quality Assurance Team Lead for our 2nd Shift to handle the Plant's Quality Control (QC) and Quality Assurance programs. This position is responsible for developing and coaching a staff of Quality Assurance Technicians and ensuring compliance with company and government...

  • Quality Assurance Team Leader

    2 weeks ago

    Lebanon, United States Ken's Foods Full time

    Great opportunity with growing company! Ken's Foods in Lebanon, IN is looking for a Quality Assurance Team Lead for our 2nd Shift to handle the Plant's Quality Control (QC) and Quality Assurance programs. This position is responsible for developing and coaching a staff of Quality Assurance Technicians and ensuring compliance with company and government...

  • Quality Assurance Team Leader

    2 weeks ago

    Lebanon, United States Ken's Foods Full time

    Great opportunity with growing company! Ken's Foods in Lebanon, IN is looking for a Quality Assurance Team Lead for our 2nd Shift to handle the Plant's Quality Control (QC) and Quality Assurance programs. This position is responsible for developing and coaching a staff of Quality Assurance Technicians and ensuring compliance with company and government...

  • Quality Assurance Team Leader

    2 weeks ago

    Lebanon, United States Ken's Foods Full time

    Great opportunity with growing company! Ken's Foods in Lebanon, IN is looking for a Quality Assurance Team Lead for our 2nd Shift to handle the Plant's Quality Control (QC) and Quality Assurance programs. This position is responsible for developing and coaching a staff of Quality Assurance Technicians and ensuring compliance with company and government...

  • Quality Supervisor

    3 days ago

    Lebanon, United States FedEx Supply Chain Full time

    **General Summary** The primary responsibility will be to meet company standards and objectives established for the storage and distribution of products to maintain product safety, quality, integrity, and legality in accordance with customer requirements, federal, state, county regulations and the Brand Recognition Compliance Global Standards...

  • Quality Assurance Team Leader

    7 days ago

    Lebanon, United States Ken's Foods Full time

    SUMMARY Responsible for developing and coaching a staff of QA Technicians and handling the Plant's Quality Control (QC) and Quality Assurance programs. Ensure compliance with company and government procedures. Inspect, audit and validate all phases of quality performance (quality at the source, raw materials, production, packaging and distribution)....

  • Quality Supervisor

    6 days ago

    Lebanon, United States FedEx Full time

    General Summary The primary responsibility will be to meet company standards and objectives established for the storage and distribution of products to maintain product safety, quality, integrity, and legality in accordance with customer requirements, federal, state, county regulations and the Brand Recognition Compliance Global Standards (BRCGS).Essential...

  • Quality Supervisor

    7 days ago

    Lebanon, United States FedEx Group Full time

    General Summary The primary responsibility will be to meet company standards and objectives established for the storage and distribution of products to maintain product safety, quality, integrity, and legality in accordance with customer requirements, federal, state, county regulations and the Brand Recognition Compliance Global Standards (BRCGS). Essential...

  • Quality Assurance Area Specialist IV

    6 days ago

    Lebanon, Oregon, United States Novo Nordisk Full time

    About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site – it's a tight-knit,...

  • Quality Supervisor

    6 days ago

    Lebanon, United States FedEx Full time

    General Summary The primary responsibility will be to meet company standards and objectives established for the storage and distribution of products to maintain product safety, quality, integrity, and legality in accordance with customer requirements, federal, state, county regulations and the Brand Recognition Compliance Global Standards (BRCGS). Essential...

  • Quality Technician I

    4 days ago

    Lebanon, United States DHL Full time

    **DHL Supply Chain is Hiring!**?** At DHL, you will play a part in one of the world’s most essential industries. As the world’s leading contract?logistics?provider, we believe in doing the right thing, growing together, and delivering the difference. At DHL, you have a voice that matters and can make an impact that lasts. There has never been a better...

  • Quality Inspector

    2 days ago

    Lebanon, United States Stratosphere Quality Full time

    Job DescriptionJob DescriptionOverviewJoin the Stratosphere Quality Team!Stratosphere Quality cultivates a positive organizational work environment, where employees are compelled to perform their best. Our team enjoys rewarding and meaningful work in a wide range of manufacturing work environments. Begin a rewarding career today and envision yourself at work...

  • Quality Inspector

    2 weeks ago

    Lebanon, United States Stratosphere Quality Full time

    Job DescriptionJob DescriptionOverviewJoin the Stratosphere Quality Team!Stratosphere Quality cultivates a positive organizational work environment, where employees are compelled to perform their best. Our team enjoys rewarding and meaningful work in a wide range of manufacturing work environments. Begin a rewarding career today and envision yourself at work...

  • ACO Compliance Program Analyst

    3 weeks ago

    Lebanon, United States Dartmouth-Hitchcock Concord Full time

    Overview The ACO Compliance Program Analyst (the "Program Analyst") is responsible for the day-to-day operations of the DH ACO Compliance Program. The Program Analyst directs the execution of proactive and reactive compliance activities, as well as maintains the core elements of the ACO Compliance Program. The role will also administer oversight to comply...

  • Rubber Formulation Chemist

    2 weeks ago

    Lebanon, United States NEWMAN SANITARY GASKET COMPANY Full time

    Company DescriptionNEWMAN SANITARY GASKET COMPANY™ is a leading manufacturer of FDA and USP Class VI seals for High Purity Process applications in industries such as Pharmaceutical, Food & Beverage, and Dairy. NEWMAN DIAPHRAGMS provides world-class replacement diaphragms for valves from ITT®, Gemü®, Saunders®, and Aquasyn®. We offer a wide selection...

  • Rubber Formulation Chemist

    2 weeks ago

    Lebanon, United States NEWMAN SANITARY GASKET COMPANY Full time

    Company DescriptionNEWMAN SANITARY GASKET COMPANY™ is a leading manufacturer of FDA and USP Class VI seals for High Purity Process applications in industries such as Pharmaceutical, Food & Beverage, and Dairy. NEWMAN DIAPHRAGMS provides world-class replacement diaphragms for valves from ITT®, Gemü®, Saunders®, and Aquasyn®. We offer a wide selection...

  • Quality Engineer Sr.

    6 days ago

    Lebanon, United States Autokiniton Full time

    Job DescriptionWe Are AUTOKINITONAUTOKINITON is a Michigan-based automotive company delivering operational excellence, high-quality execution, and customer service. We offer 100% vertical integration capabilities such as end-to-end engineering, manufacturing, and in-house logistics.We're proud of our Tier 1 supplier legacy for manufacturing...

  • Director of Quality

    3 weeks ago

    Lebanon, United States West Central Behavioral Health Full time

    DescriptionWest Central Behavioral Health is seeking a full-time Director of Quality.The Director of Quality will oversee agency-wide, quality and evaluation activities including: design & delivery of evaluation protocols, gathering clinic-level measures, organizing & analyzing collected data, preparing performance reports, and implementing/assessing...

  • Director of Quality

    19 hours ago

    Lebanon, United States West Central Behavioral Health Full time

    Description West Central Behavioral Health is seeking a full-time Director of Quality. The Director of Quality will oversee agency-wide, quality and evaluation activities including: design & delivery of evaluation protocols, gathering clinic-level measures, organizing & analyzing collected data, preparing performance reports, and implementing/assessing...