Director of Quality Assurance and Regulatory Affairs

4 days ago


Gardner, Massachusetts, United States Precision Optics Corporation Inc Full time
Job Summary

The Director of Quality Assurance and Regulatory Affairs will be responsible for ensuring that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards. This role will oversee all quality assurance and regulatory functions across the company's Portland and Gardner sites.

Key Responsibilities
  • Regulatory Compliance: Ensure that the company's products meet applicable regulatory requirements and quality standards.
  • Quality Management: Develop and implement quality and regulatory strategies, policies, programs, and procedures to ensure compliance with current and future regulations.
  • Leadership: Provide leadership to the QA/RA team, mentor, retain, and develop departmental talent.
  • Collaboration: Foster a collaborative and high-performance culture based on Lean and continuous improvement principles.
  • Communication: Interface with key customers during negotiations relating to quality plans, agreements, and regulatory requirements.
Requirements
  • Experience: 8 to 10 years of experience in quality assurance and regulatory affairs, preferably in process-oriented manufacturing operations in a regulated environment.
  • Leadership: Minimum 3 years of experience leading quality management within a significant segment of a large manufacturer or the entire operation of a smaller manufacturer.
  • Regulatory Knowledge: Minimum 3 years of experience in medical devices and FDA QSR, ISO 13485 & EU MDR; defense/aerospace industry experience desired.
  • Education: Bachelor's degree in engineering, or a related technical/science field. Master's degree preferred.
Competencies
  • Regulatory Knowledge: In-depth understanding of quality assurance and engineering and related tools, FDA QSR, EU MDR, MDSAP, and ISO standards relating to regulation of Medical Devices.
  • Leadership: Strong leadership and people skills, with the ability to identify/develop talent, and inspire others to achieve.
  • Communication: Strong data collection & analysis, problem-solving, presentation, and communication skills.

  • Director of Nursing

    12 hours ago


    Gardner, Massachusetts, United States HealthEcareers - Client Full time

    Job SummaryWe are seeking a highly skilled and experienced Director of Nursing to join our team at HealthEcareers - Client. As a key member of our healthcare leadership team, the Director of Nursing will be responsible for overseeing the delivery of high-quality patient care services in a correctional setting.Key ResponsibilitiesSupervise and coordinate the...


  • Gardner, Massachusetts, United States Making Opportunity Count Inc Full time

    About Us: About Us: Making Opportunity Count is a non-profit human services organization dedicated to fostering positive change and improving the lives of individuals and families in Central Massachusetts. We are committed to promoting community development, delivering essential services, and enhancing holistic well-being. ~ Comprehensive Health, Dental, and...

  • Medical Director

    7 days ago


    Gardner, Massachusetts, United States VitalCore Health Strategies Full time

    Job SummaryVitalCore Health Strategies, a leading provider of correctional healthcare services, is seeking a highly skilled and experienced Director of Nursing to join our team. As a key member of our leadership team, the Director of Nursing will be responsible for overseeing the delivery of high-quality nursing services in a correctional setting.Key...

  • Travel Nurse RN

    7 days ago


    Gardner, Massachusetts, United States TravelNurseSource Full time

    Job DescriptionTravelNurseSource is partnering with ICONMA, L.L.C. to find a qualified Care Coordinator in a dynamic healthcare setting.About the PositionAs a Registered Nurse Care Coordinator, you will play a crucial role in ensuring seamless patient care transitions and efficient hospital operations.Key ResponsibilitiesUtilization Management: Conduct...


  • Gardner, Massachusetts, United States VitalCore Health Strategies Full time

    Job SummaryVitalCore Health Strategies is seeking a highly skilled and experienced Director of Nursing to lead our nursing department in Massachusetts. As a key member of our team, you will be responsible for overseeing the delivery of high-quality nursing care to our patients.Key ResponsibilitiesLeadership and ManagementSupervise and coordinate the...


  • Gardner, Massachusetts, United States VitalCore Health Strategies Full time

    Job SummaryVitalCore Health Strategies is seeking a highly skilled and experienced Director of Nursing to lead our nursing department in Massachusetts. As a key member of our team, you will be responsible for overseeing the delivery of high-quality nursing care to our patients.Key ResponsibilitiesLeadership and ManagementSupervise and coordinate the...


  • Gardner, Massachusetts, United States Focus Staff Full time

    Job DescriptionWe are seeking a highly skilled and motivated Cardiac Sonographer to join our team at Focus Staff. As a Diagnostic Medical Sonographer, you will be responsible for conducting multi-specialty diagnostic ultrasound examinations according to departmental procedures.Key Responsibilities:Conduct diagnostic ultrasound examinations for patients with...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    Assured Nursing is actively seeking a skilled CT Technologist for a travel assignment.Position OverviewSpecialty: CT TechnologistField: Allied Health ProfessionalDuration: 13 weeksWeekly Hours: 36 hoursShift: 12-hour night shiftsEmployment Type: TravelThis role involves working as a CT Tech in a contract capacity. The position requires a current state...

  • Hospice Nurse

    1 week ago


    Gardner, Massachusetts, United States Care Central VNA & Hospice Full time

    About the RoleCare Central VNA & Hospice is seeking a skilled Registered Nurse to join our Hospice team. As a member of our team, you will work under the general direction of the Hospice Director and the attending physician/hospice medical director to provide care to patients and families.Key ResponsibilitiesImplement, coordinate, and supervise all aspects...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    Assured Nursing is currently in search of a Travel Registered Nurse specializing in Psychiatric Care for an exciting opportunity. This position offers a chance to work in a dynamic environment while providing essential care to patients.Position OverviewSpecialty: PsychiatricDiscipline: Registered Nurse (RN)Employment Type: TravelWeekly Hours: 40 hoursShift:...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    Assured Nursing is currently seeking a Travel CT Technologist for an exciting opportunity. This role involves providing high-quality imaging services in a travel capacity.Position OverviewSpecialty: CT TechnologistDiscipline: Allied Health ProfessionalEmployment Type: TravelThe ideal candidate will hold a valid state license as a CT Technologist and have a...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    Position Overview:Assured Nursing is currently in search of a skilled Echo Technologist for a travel assignment. This role is essential for providing high-quality echocardiography services.Key Responsibilities:- Perform echocardiograms and assist in diagnostic procedures.- Collaborate with healthcare professionals to ensure optimal patient care.- Maintain...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    Assured Nursing is currently seeking a dedicated CT Technologist for a travel assignment. This role is ideal for professionals looking to expand their experience in diverse settings.Position OverviewSpecialty: CT TechnologistDiscipline: Allied Health ProfessionalDuration: 13 weeksWeekly Hours: 36 hoursShift: 12-hour night shiftsEmployment Type: TravelThe...


  • Gardner, Massachusetts, United States Uniti Med Full time

    Uniti Med is seeking a skilled Radiology Imaging Specialist to fill a travel position in a dynamic healthcare setting.Job SummaryThis is a 13-week contract opportunity for a dedicated Diagnostic Imaging Professional to work in a fast-paced environment.Key ResponsibilitiesOperate and maintain CT scanners to produce high-quality diagnostic imagesCollaborate...


  • Gardner, Massachusetts, United States ADN Healthcare Full time

    ADN Healthcare is seeking a skilled Diagnostic Imaging Specialist for a travel opportunity in a dynamic healthcare setting.Job SummaryWe are looking for a highly motivated and experienced Diagnostic Imaging Specialist to join our team as a Travel Radiologic Technologist. As a key member of our healthcare team, you will be responsible for operating imaging...


  • Gardner, Massachusetts, United States ADN Healthcare Full time

    Job Title: Travel Mammography TechnologistJob Type: Travel HealthcareLocation: Gardner, MassachusettsJob Description:We are seeking a skilled Mammography Technologist to join our team as a Traveling Mammography Imaging Specialist. As a key member of our healthcare team, you will be responsible for providing high-quality mammography services to patients in a...


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

    Job SummaryCross Country Allied is seeking a skilled CT Technologist to join our team for a travel assignment in a dynamic healthcare setting.Key Responsibilities:Operate computerized tomography equipment to produce high-quality medical images for diagnostic purposes.Prepare patients for CT scans, ensuring their safety and comfort throughout the...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    **Job Summary**Assured Nursing is seeking a skilled Psychiatric Travel Nurse RN to join our team. This is a contract position that requires a current state license as a RN and at least 2 years of recent experience as a Psych RN.**Job Responsibilities**Provide high-quality patient care in a psychiatric settingCollaborate with healthcare teams to develop and...


  • Gardner, Massachusetts, United States Assured Nursing Full time

    Position OverviewAssured Nursing is currently in search of a skilled Mammography Technician for a travel assignment. This role is essential in providing high-quality imaging services to patients.Key Details:Specialty: Mammography TechnicianDiscipline: Allied Health ProfessionalDuration: 13 weeksHours: 36 hours per weekShift: 12-hour day shiftsEmployment...


  • Gardner, Massachusetts, United States Planet Healthcare Full time

    Job SummaryPlanet Healthcare is seeking a skilled Mammography Technologist to join our team for a travel assignment in Massachusetts.Key ResponsibilitiesPerform high-quality mammography procedures for patientsOperate and maintain mammography equipmentDevelop and implement patient care plansCollaborate with radiologists and other healthcare...