Product Quality Assurance Specialist

3 days ago

Wilmington, Massachusetts, United States ConforMIS Full time
Job Summary:

The Product Quality Engineer will be responsible for ensuring the quality and reliability of our medical devices. This includes interpreting and implementing quality standards, conducting quality testing, and developing and maintaining quality systems.

Key Responsibilities:
  • Develop and maintain strong internal working relationships across Conformis.
  • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Perform quality testing of CER and Purified water system.
  • Perform product release activities (on an as needed basis).
  • Administer the bioburden/endotoxin testing program as required per procedure.
  • Trend in-process manufacturing data and environmental monitoring data and produce summary reports.
  • Implement and maintain quality system in accordance to applicable regulatory requirements.
  • Initiate and participate in resolution of non-conforming materials.
  • Review Non-Conformity Reports for sub-assemblies and finished goods.
  • Administer the calibration system.
  • Review of the daily activities for production start-up.
  • Develop and upgrade procedures for continuous improvement as required by the quality system.
  • Perform Internal Quality Audits of the quality system.
  • Develop qualification/validation plans.
  • Conduct product/process validations (sterilization).
  • Develop and implement statistical sampling plans.
  • Assist in the investigation of product complaints.
  • Assist in corrective action investigations.
  • Perform internal audits to drive continuous improvement (minimum of 2 per year).
  • Other responsibilities as assigned.
Qualifications:
  • Bachelor of Science in Engineering or Science.
  • 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications).
Skills, Abilities, and Competencies:
  • Excellent written and verbal communication skills.
  • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
  • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
  • Strong organizational, analytical, and time-management skills.
  • Able to self-motivate and work both independently and as part of a team.
  • Must have a solid knowledge of Microsoft office 2010.
  • Knowledge of FDA and ISO standards for Medical Devices is a plus.
  • Knowledge of Statgraphics or Minitab is a plus.
About Conformis:

Conformis is an Equal Opportunity Employer.

  • Quality Assurance Manager

    3 weeks ago

    Wilmington, Massachusetts, United States Source Recruitment Solutions Full time

    Quality Assurance Manager Job DescriptionWe are seeking an experienced Quality Assurance Manager to join our team at Source Recruitment Solutions. The successful candidate will be responsible for ensuring the highest quality standards in our food manufacturing plant.Key Responsibilities:Develop and implement quality control programs to ensure compliance with...

  • Quality Assurance Manager

    1 month ago

    Wilmington, Massachusetts, United States Jobot Full time

    {"title": "Quality Assurance Manager", "company": "Jobot", "job_details": "Job SummaryWe are seeking a highly skilled Quality Assurance Manager to lead our food safety and quality program. The successful candidate will be responsible for implementing and executing the facility's food safety and quality program, ensuring compliance with regulatory...

  • Quality Assurance Inspector

    4 days ago

    Wilmington, Massachusetts, United States SOC Full time

    Quality Tech Process Inspector Job DescriptionWe are seeking a highly skilled Quality Tech Process Inspector to join our team at SOC, a Day & Zimmermann company. As a Quality Tech Process Inspector, you will play a critical role in ensuring the quality of our products and processes.Responsibilities:Analyze measurement results and provide comprehensive...

  • Quality Assurance Inspector

    3 days ago

    Wilmington, Massachusetts, United States SOC Full time

    Quality Tech Process Inspector Job DescriptionWe are seeking a highly skilled Quality Tech Process Inspector to join our team at SOC, a Day & Zimmermann company. As a Quality Tech Process Inspector, you will play a critical role in ensuring the quality of our products and processes.Responsibilities:Analyze measurement results and provide comprehensive...

  • Quality Assurance Manager

    2 weeks ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    Job Title: Quality Systems Engineering ManagerThis role will require collaboration across departments, ADI manufacturing sites, leading cross-functional audit teams, Quality Systems deployment, and standardizing best practices across ADI sites globally.Key Responsibilities:Lead and/or collaborate with cross-functional teams and departments to ensure...

  • Production Operator

    3 weeks ago

    Wilmington, Massachusetts, United States Mitsubishi Chemical Performance Polymers Full time

    Job Title: Production OperatorMitsubishi Chemical Performance Polymers is seeking a skilled Production Operator to join our team. As a key member of our production team, you will be responsible for ensuring the efficient and safe operation of our production processes.Key Responsibilities:Operate production machinery and equipment, including extruders and cut...

  • Senior Medical Quality Engineer

    2 days ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    Job Title: Senior Medical Quality EngineerAnalog Devices, Inc. is a global leader in semiconductor technology, bridging the physical and digital worlds to drive innovation at the Intelligent Edge. Our company combines analog, digital, and software technologies to create solutions that enable breakthroughs in digitized factories, mobility, and digital...

  • Senior Medical Quality Engineer

    4 days ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    Job Title: Senior Medical Quality EngineerAnalog Devices, Inc. is a global leader in semiconductor technology, and we are seeking a highly skilled Senior Medical Quality Engineer to join our team. As a Senior Medical Quality Engineer, you will be responsible for ensuring the quality of our medical products, from design to delivery.Responsibilities:Develop...

  • Reliability Operations Specialist

    4 days ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    Reliability Operations SpecialistAnalog Devices, a global leader in semiconductor technology, is seeking a highly motivated and detail-oriented Reliability Operations Specialist to join our team. As a key member of our reliability operations team, you will play a critical role in ensuring the quality and reliability of our products.Key...

  • Production Supervisor

    2 days ago

    Wilmington, Massachusetts, United States LightForce Orthodontics Full time

    About LightForce OrthodonticsLightForce Orthodontics is a pioneering 3D printing technology company revolutionizing the orthodontic space. Our cutting-edge digital platform empowers orthodontists with fully customized, 3D-printed tooth-moving tools. In 2019, we launched our first product - the world's only, fully customized 3D printed bracket system and...

  • Quality Control Supervisor

    3 weeks ago

    Wilmington, Massachusetts, United States Curtiss-Wright Full time

    Job Title: Quality Control SupervisorWe are seeking a highly skilled Quality Control Supervisor to join our team at Curtiss-Wright Surface Technologies in Wilmington, MA.Job Summary:The Quality Control Supervisor will be responsible for overseeing the inspection and testing of materials, parts, and products to ensure adherence to customer and regulatory...

  • Marketing Programs Specialist

    4 weeks ago

    Wilmington, Massachusetts, United States LEDVANCE Full time

    {"title": "Marketing Programs Specialist", "description": "About LEDVANCEAs a leading general lighting company, LEDVANCE offers a wide range of innovative luminaires, smart lighting solutions, and electronic components. With a strong presence in over 150 countries, we provide professional customers and end-consumers with high-quality products and...

  • Senior Inertial Sensors and IMU Product Specialist

    3 days ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    Job Title: Senior Inertial Sensors and IMU Product EngineerAnalog Devices, a global leader in semiconductor innovation, is seeking a highly skilled Senior Inertial Sensors and IMU Product Engineer to join our team. As a key member of our MEMS Group, you will be responsible for supporting our extensive portfolio of System level products based on MEMS...

  • Production Planner

    4 days ago

    Wilmington, Massachusetts, United States Yoh Full time

    Job Title: Production PlannerYoh, a leading global staffing company, is seeking a highly skilled Production Planner to join our team. As a Production Planner, you will play a critical role in ensuring the smooth operation of our manufacturing processes.Job Summary:The Production Planning organization is looking for an individual who can effectively bridge...

  • Senior Inertial Sensors and IMU Product Specialist

    3 days ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    About the RoleAnalog Devices, a global leader in semiconductor innovation, is seeking a highly skilled Engineer to join our MEMS Group in Wilmington, MA. As a key member of our team, you will play a critical role in supporting our extensive portfolio of System level products (IMUs) based on MEMS sensors.Key ResponsibilitiesCollaborate with our assembly and...

  • Production Supervisor

    3 weeks ago

    Wilmington, Massachusetts, United States Monogram Foods Full time

    About Monogram FoodsMonogram Foods is a dynamic and innovative company in the food manufacturing industry, passionate about creating top-quality food products that delight consumers across the United States. With a diverse portfolio that includes meat snacks, appetizers, assembled sandwiches, fully cooked and raw bacon, corn dogs, USDA baked goods, and other...

  • Quality Systems Engineering Manager

    14 minutes ago

    Wilmington, Massachusetts, United States Analog Devices Full time

    Job Title: Quality Systems Engineering ManagerAnalog Devices, Inc. is a global leader in semiconductor technology, bridging the physical and digital worlds to enable breakthroughs at the Intelligent Edge. As a Quality Systems Engineering Manager, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Lead...

  • Quality Tech Process Inspector

    2 days ago

    Wilmington, Massachusetts, United States SOC Full time

    Job Title: Quality Tech Process InspectorWe are seeking a highly skilled Quality Tech Process Inspector to join our team at SOC, a Day & Zimmermann company. As a Quality Tech Process Inspector, you will be responsible for ensuring the quality of our products and processes.Responsibilities:Analyze measurement results and provide comprehensive reports to...

  • Animal Care Specialist

    2 hours ago

    Wilmington, Massachusetts, United States Charles River Laboratories Full time

    Job SummaryWe are seeking a highly skilled Animal Care Specialist to join our team at Charles River Laboratories. The successful candidate will be responsible for maintaining and monitoring the health, production, and physical environment of animals within isolators, micro-isolator cages, or barrier rooms.Key Responsibilities: Perform specialized production...

  • Interim Behavior Specialist

    3 weeks ago

    Wilmington, Massachusetts, United States May Institute Full time

    Job Title: Interim Behavior SpecialistMay Institute is seeking a highly skilled and dedicated Interim Behavior Specialist to join our team at the May Center Schools for Autism and Developmental Disabilities in Wilmington, MA.About the Role:We are looking for a motivated and compassionate individual to provide educational and behavioral services to children...