Quality Assurance Validation Specialist

1 week ago


Newburyport, Massachusetts, United States UFP Technologies Full time
Job Overview

About UFP MedTech:

UFP Technologies specializes in designing and manufacturing tailored solutions for medical devices, sterile packaging, and other highly engineered products. As a crucial player in the medical device supply chain, UFP serves as a trusted outsourcing partner for leading medical device manufacturers globally. The company's single-use and single-patient devices and components are integral to various medical applications, including minimally invasive surgery, infection control, wound management, wearable technology, orthopedic soft goods, and implants.

Benefits:

  • Comprehensive Medical, Dental, Vision, Life, and Disability Insurance
  • 401K Plan with Employer Matching
  • Generous Paid Time Off, Holidays, and Employee Discounts

Position Summary:

The Validation Engineer is responsible for spearheading validation initiatives for new products and processes. This role involves working independently with medical clients or as part of cross-functional teams to formulate and implement validation protocols. Collaborating with project engineers, program managers, quality assurance, and production teams is essential to create processes that meet customer specifications while achieving optimal production rates and material yields.

Key Responsibilities:

  • Collaborate with medical clients, guided by program management and design engineers, to establish quality requirements and validation protocols (IQ, OQ, PQ, PPAP).
  • Conduct statistical analyses to support process validations.
  • Provide hands-on design assistance using tools such as SolidWorks, CAD, and statistical software to develop new products that align with customer needs.
  • Act as the technical point of contact as necessary, overseeing projects from development through production transfer, including validation.
  • Educate team members on operational parameters to ensure quality product output.
  • Engage in individual tasks and collaborate with cross-functional teams to develop, enhance, and launch medical products and manufacturing processes.
  • Draft work instructions and inspection documentation.
  • Compose clear technical reports regarding both existing and newly developed processes.
  • Train operators and quality personnel on work instructions and inspection protocols.
  • Manage projects to meet or exceed timelines and budget constraints.
  • Identify and escalate issues as needed, proposing solutions to fulfill customer requirements and business profitability objectives.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in Engineering or a related technical field (e.g., polymer science, material science, chemistry) with 3-5 years of relevant experience in medical packaging, supply chain, or device design.
  • At least three years of experience in product validation.
  • Strong statistical background, proficient in Minitab SixPack for process validations.
  • Familiarity with change control processes and management.
  • Knowledge of thermoplastics, foamed plastics, and manufacturing processes used in medical packaging.
  • Understanding of sterilization requirements for medical packaging.
  • Solid project management capabilities, including the ability to manage multiple projects, identify critical paths, and navigate new product introduction (NPI) processes.
  • Familiarity with medical device qualification standards and quality management systems such as ISO 13485, ISO 17664, and 21 CFR 820 regulations.
  • Hands-on experience in collaborating with medical clients to develop quality requirements and validation protocols (IQ, OQ, PQ, PPAP).
  • Experience in drafting work instructions and inspection documentation.
  • Able to instruct operators and quality personnel on work instructions and inspection procedures.
  • Proficient in writing clear technical reports on existing and newly developed processes.
  • Demonstrated project management experience with a track record of meeting deadlines.
  • Strong understanding of manufacturing processes, with the ability to communicate effectively on the production floor.
  • Comfortable addressing issues and proposing solutions to meet customer expectations and business goals.
  • Willingness to travel occasionally (


  • Newburyport, Massachusetts, United States UFP Technologies Full time

    Job OverviewAbout UFP Technologies:UFP Technologies is a leading designer and custom manufacturer specializing in comprehensive solutions for medical devices, sterile packaging, and other highly engineered products. As a crucial component in the medical device supply chain, UFP serves as a trusted outsourcing partner for many of the world's top medical...


  • Newburyport, Massachusetts, United States UFP Technologies Full time

    Job OverviewAbout UFP MedTech:UFP Technologies specializes in designing and manufacturing tailored solutions for medical devices, sterile packaging, and other highly engineered products. As a crucial component in the medical device supply chain, UFP serves as a trusted outsourcing partner for leading medical device manufacturers globally. The company’s...


  • Newburyport, Massachusetts, United States UFP Technologies Full time

    About UFP Technologies:UFP Technologies is a leading designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. As an important link in the medical device supply chain, UFP Technologies is a valued outsource partner to most of the top medical device manufacturers in the...


  • Newburyport, Massachusetts, United States DaPro Rubber, Inc. Full time

    Job OverviewLOCATION: Newburyport, MAPOSITION SUMMARYDaPro Rubber, Inc. is seeking a Quality Control Specialist. The Quality Control Specialist is tasked with the evaluation and testing of products to ensure they meet quality standards. This role involves utilizing various inspection and testing instruments.This position necessitates strict adherence to...


  • Newburyport, Massachusetts, United States The FootBridge Companies Full time

    Quality Control Technician1st Shift, 7AM-3:30PMTemporary to permanent position availableThe Quality Control Technician is responsible for evaluating, visually examining, measuring, and counting microelectronic components such as die and wafer, caps, bases, lead frames, and various other parts intended for assembly. This position encompasses Quality...


  • Newburyport, Massachusetts, United States American Traveler Full time

    Job Title: Traveling Medical Imaging SpecialistJob Type: Full-time, ContractLocation: Newburyport, MassachusettsJob Description:Job Summary:American Traveler is seeking a skilled Traveling Medical Imaging Specialist to join our team. As a Traveling Medical Imaging Specialist, you will be responsible for performing diagnostic imaging procedures and providing...


  • Newburyport, Massachusetts, United States Port Signworks Full time

    Signage Installation SpecialistComprehensive Job Overview:Port Signworks is seeking skilled and committed individuals to become part of our dynamic team.Position Summary:The Signage Installation Specialist is responsible for the production, setup, and removal of signs and graphics for both new and existing clients. This role involves creating and installing...


  • Newburyport, Massachusetts, United States OneStaff Medical Full time

    Job Title: Diagnostic Imaging SpecialistWe are seeking a skilled Diagnostic Imaging Specialist to join our team at OneStaff Medical. As a Diagnostic Imaging Specialist, you will be responsible for operating and maintaining medical imaging equipment, preparing patients for exams, and interpreting images to aid in diagnosis.Job Summary:Operate and maintain...


  • Newburyport, Massachusetts, United States Cross Country Allied Full time

    Job SummaryAt Cross Country Allied, we are seeking a skilled Diagnostic Imaging Specialist to join our team. As a Diagnostic Imaging Specialist, you will be responsible for operating medical imaging equipment to produce high-quality images of patients' hearts.Key Responsibilities:Prepare patients for echocardiograms, ensuring their comfort and safety...


  • Newburyport, Massachusetts, United States PHP Full time

    Job Title: Travel Vascular Imaging SpecialistJob Summary:We are seeking a skilled Travel Vascular Imaging Specialist to join our team at PHP. As a Travel Vascular Imaging Specialist, you will be responsible for performing echocardiograms and vascular ultrasounds to diagnose and treat cardiovascular diseases.Responsibilities:Perform echocardiograms and...


  • Newburyport, Massachusetts, United States HW Staffing Solutions Full time

    We are looking for a proficient Microelectronics Assembly Specialist to become a part of our dynamic team. This position offers opportunities for growth and development within our organization.Key Responsibilities:Equipment Operation: Manage and operate a variety of manual, automatic, and semi-automatic microelectronics assembly machinery.Quality Inspection:...


  • Newburyport, Massachusetts, United States Voca Full time

    Job Title: Traveling Cardiac Sonographer SpecialistJob Type: Full-time, TravelingLocation: RemoteJob Description:The Cardiac Sonographer Specialist will be responsible for performing high-quality cardiac ultrasound procedures, including m-mode, 2D (pw/cw doppler, color flow imaging, transesophageal, and contrast studies). The ideal candidate will have...

  • Travel Nurse RN

    15 hours ago


    Newburyport, Massachusetts, United States OneStaff Medical Full time

    Job Title: Travel Nurse RN - Ambulatory Care SpecialistJob Summary:OneStaff Medical is seeking a skilled Travel Nurse RN - Ambulatory Care Specialist to join our team. As a Travel Nurse RN - Ambulatory Care Specialist, you will be responsible for providing high-quality patient care in a variety of ambulatory care settings.Responsibilities:Provide medical...


  • Newburyport, Massachusetts, United States Voca Full time

    Job Title: Traveling Cardiac Sonographer SpecialistJob Type: Full-time, TravelingLocation: Remote, NationwideJob Description:We are seeking a highly skilled and experienced Cardiac Sonographer to join our team as a Traveling Cardiac Sonographer Specialist. As a key member of our team, you will be responsible for performing professional quality cardiac...

  • Electronic Tester

    6 days ago


    Newburyport, Massachusetts, United States Careers Integrated Resources Inc Full time

    **Job Title:** Electronic Tester - Production Specialist**Job Summary:** We are seeking a skilled Electronic Tester to join our team at Careers Integrated Resources Inc. as a Production Specialist. In this role, you will be responsible for testing and inspecting electronic components in a fast-paced production environment.**Key Responsibilities:**Set up and...


  • Newburyport, Massachusetts, United States Adecco Full time

    Job SummaryAdecco is seeking an experienced Electromechanical Assembly Specialist to join our team in a temp-to-hire opportunity. This role involves performing a wide range of tasks associated with the manufacture of electronic and electromechanical products within a controlled environment.Key ResponsibilitiesAssemble a diverse group of industrial electronic...

  • Culinary Specialist

    4 days ago


    Newburyport, Massachusetts, United States KinderCare Education Full time

    About KinderCare EducationKinderCare Education is a leading provider of early childhood education and child care services. We are committed to delivering high-quality programs that support the development of young children and their families.Job SummaryWe are seeking a skilled Culinary Specialist to join our team at our Newburyport KinderCare center. As a...


  • Newburyport, Massachusetts, United States Tekaccel, Inc. Full time

    Job SummaryTekaccel, Inc. is seeking a skilled Travel Medical Imaging Specialist to join their team. As a Diagnostic Imaging Technologist, you will be responsible for operating medical imaging equipment to produce high-quality images for diagnostic purposes.Key ResponsibilitiesOperate various types of medical imaging equipment, including ultrasound, MRI, and...

  • Culinary Specialist

    4 days ago


    Newburyport, Massachusetts, United States KinderCare Education Full time

    About KinderCare EducationKinderCare Education is a leading provider of early childhood education and child care services. Our mission is to provide high-quality, research-backed programs that support the development of young learners and their families.Job SummaryWe are seeking a skilled Culinary Specialist to join our team at KinderCare Education in...

  • Travel Nurse RN

    4 days ago


    Newburyport, Massachusetts, United States OneStaff Medical Full time

    Job Title: Travel Nurse RN - Ambulatory Care SpecialistJob Summary:OneStaff Medical is seeking a skilled Travel Nurse RN - Ambulatory Care Specialist to join our team. As a Travel Nurse RN - Ambulatory Care Specialist, you will be responsible for providing high-quality patient care in a variety of ambulatory care settings.Responsibilities:Provide direct...