Quality Assurance and Regulatory Compliance Specialist II

3 weeks ago

Saco, Maine, United States MMQCI Full time
Position Overview:
The Quality Assurance and Regulatory Compliance Specialist II plays a pivotal role in ensuring that all quality assurance activities align with regulatory standards. This position involves conducting audits, reviewing documentation, and analyzing data to maintain compliance with industry regulations. Under the guidance of the QA/RA Manager, the Specialist II will implement and uphold policies and systems that ensure adherence to the company's Quality System, in accordance with federal regulations. The ideal candidate will possess a robust background in the in vitro diagnostic sector and be adept at managing a Quality System compliant with relevant regulations.

Key Responsibilities:
  1. Review and validate all quality system documentation to ensure alignment with established protocols and regulatory standards, including Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs), and Corrective and Preventive Actions (CAPAs). Collaborate with various departments to investigate MRNs and establish CAPAs addressing root causes.
  2. Evaluate and approve validations for new equipment and processes.
  3. Conduct internal and supplier audits, providing support during FDA and customer audits.
  4. Compile Device Master Records for new products.
  5. Oversee training documentation for all personnel.
  6. Maintain ISO 13485 certification and contribute to Technical Files for CE marking, while managing international product registrations.
  7. Prepare and submit FDA pre-submissions, de novo requests, and 510(k) submissions for Class II products, ensuring compliance with FDA registration requirements.
  8. Interpret regulations and policies for staff, communicating their implications for product development, manufacturing, and marketing.
  9. Stay informed on regulatory trends affecting products, assessing their impact on QA/RA teams and product development.
  10. Participate in and conduct audits, including internal, customer, FDA, and ISO audits.
  11. Collaborate with QA/RA and other staff to review and approve product labeling changes, promotional materials, and manage non-conforming products.
  12. Deliver training sessions on various regulatory topics to cross-functional teams.
  13. Draft SOPs and provide training to key personnel as necessary.
  14. Perform additional duties as assigned, including monitoring and enhancing the quality system and overseeing post-market surveillance and recalls.
Qualifications:
  1. Bachelor's degree in Life Sciences with a minimum of 5 years of experience in a cGMP regulated environment and at least 2 years in Quality Assurance.
  2. Exceptional proofreading abilities.
  3. Comprehensive knowledge of current GMP regulations.
  4. Detail-oriented with a strong understanding of ISO 13485.
  5. Familiarity with In Vitro Diagnostic Regulation (IVDR) is preferred.
  6. Experience in laboratory medicine is advantageous.
  7. Strong written and verbal communication skills, with proficiency in computer applications, including Excel.
  8. Able to manage multiple tasks in a dynamic environment with shifting priorities.
  9. Demonstrated strong work ethic and ability to meet deadlines.
  10. Willingness to learn and collaborate effectively within a team.
  11. Ability to communicate effectively to address non-conforming practices.
  12. Must adhere to non-smoking policies to prevent product contamination.
Benefits:
• Medical insurance
• Dental insurance
• 401(k) plan
• Profit sharing
• Paid vacation
• Holidays
• Sick leave

  • Quality Assurance and Regulatory Compliance Specialist II

    3 weeks ago

    Saco, Maine, United States MMQCI Full time

    POSITION TITLE:Quality Assurance/Regulatory Affairs Specialist IIGENERAL SUMMARY:The Quality Assurance/Regulatory Affairs (QA/RA) Specialist II plays a crucial role in overseeing quality assurance and ensuring adherence to relevant regulatory standards. This position involves conducting audits and meticulously reviewing and analyzing documentation and data....

  • Quality Assurance and Regulatory Compliance Specialist II

    2 weeks ago

    Saco, Maine, United States MMQCI Full time

    Job OverviewPosition: Quality Assurance/Regulatory Affairs Specialist IICompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is a pioneering organization focused on the design, development, and manufacturing of innovative quality control solutions for hospital laboratories. Our products are essential for ensuring the accuracy of tests related to...

  • Quality Assurance and Regulatory Compliance Specialist II

    2 weeks ago

    Saco, Maine, United States MMQCI Full time

    Position Overview: The Quality Assurance and Regulatory Affairs (QA/RA) Specialist II plays a crucial role in ensuring adherence to quality standards and regulatory compliance within the organization. This position involves conducting audits, reviewing documentation, and analyzing data to maintain the integrity of the quality management system. Company...

  • Quality Assurance and Regulatory Compliance Specialist II

    2 weeks ago

    Saco, Maine, United States MMQCI Full time

    Position Overview: The Quality Assurance/Regulatory Affairs Specialist II plays a crucial role in ensuring adherence to quality standards and regulatory compliance within the organization. This position involves conducting audits, analyzing data, and reviewing documentation to maintain the integrity of the quality system. Key Responsibilities: Review and...

  • Quality Assurance Specialist II in Regulatory Affairs

    3 weeks ago

    Saco, Maine, United States MMQCI Full time

    Job OverviewPosition: Quality Assurance/Regulatory Affairs Specialist IICompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, manufacturing, and marketing of innovative quality control solutions utilized by hospital laboratories. Our products are essential for ensuring the accuracy of tests related to...

  • Regulatory Affairs and Quality Control Specialist II

    3 weeks ago

    Saco, Maine, United States MMQCI Full time

    Job OverviewPosition: Quality Assurance/Regulatory Affairs Specialist IICompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, and manufacturing of innovative quality control products utilized by hospital laboratories for the accurate monitoring of tests related to inherited diseases, pharmacogenetics,...

  • Quality Assurance and Compliance Analyst

    3 weeks ago

    Saco, Maine, United States MMQCI Full time

    Job OverviewPosition: Quality Assurance/Regulatory Affairs AssociateCompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, manufacturing, and marketing of innovative quality control solutions utilized by hospital laboratories to ensure the precision of tests for hereditary conditions, cancer, and infectious...

  • Quality Control and Regulatory Compliance Specialist

    3 weeks ago

    Saco, Maine, United States MMQCI Full time

    Job OverviewPosition: Quality Assurance/Regulatory Affairs AssociateCompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, manufacturing, and marketing of innovative quality control solutions utilized by laboratory facilities to ensure the precision of diagnostic tests for genetic disorders, cancer, and...

  • Regulatory Affairs and Quality Assurance Coordinator

    3 weeks ago

    Saco, Maine, United States MMQCI Full time

    Job OverviewPosition: Quality Assurance/Regulatory Affairs AssociateCompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, and manufacturing of innovative quality control solutions utilized by hospital laboratories. Our products are essential for ensuring the accuracy of tests related to inherited diseases,...

  • Lead Quality Assurance Specialist

    3 weeks ago

    Saco, Maine, United States Unavailable Full time

    Position Title: Senior Quality Assurance EngineerCompany: UnavailableCompany Overview: Unavailable is a prominent entity in the defense sector, specializing in the production of advanced weapon systems for various applications including land, sea, and air. Our commitment to cutting-edge design and development ensures the delivery of superior products through...

  • Lead Quality Assurance Specialist

    3 weeks ago

    Saco, Maine, United States Unavailable Full time

    Position Title: Senior Quality Assurance EngineerCompany: UnavailableCompany Overview: Unavailable is a prominent entity in the defense sector, specializing in the production of advanced weapon systems for various applications including land, maritime, and aerial operations. Our commitment to pioneering design and innovation drives us to produce superior...

  • Senior Electronics Engineer II

    3 days ago

    Saco, Maine, United States Franklin Electric Fueling Full time

    Job DescriptionThe Senior Electronics Engineer II is a key member of the Franklin Electric Fueling team, responsible for leading the development of new electronic products and technologies. This role requires a strong technical background in electronics engineering, with expertise in design, development, and testing of complex electronic systems.Key...

  • Lead Quality Assurance Specialist

    2 weeks ago

    Saco, Maine, United States Unavailable Full time

    Position Title: Senior Quality Assurance EngineerCompany: UnavailableCompany Overview: Unavailable is recognized for its commitment to excellence in the manufacturing sector, specializing in advanced systems for various applications. Our mission is to innovate and enhance product quality through cutting-edge technologies and processes.Role Overview:The...

  • Travel Imaging Specialist

    2 weeks ago

    Saco, Maine, United States Assured Nursing Full time

    **Job Summary**Assured Nursing is seeking a skilled Diagnostic Imaging Professional to join our team as a Travel Imaging Specialist. This is a 13-week contract position in York, Maine.**Job Responsibilities**Operate and maintain imaging equipment, including CT scanners, to produce high-quality diagnostic images.Assist patients with positioning and preparing...

  • Travel Imaging Specialist

    2 weeks ago

    Saco, Maine, United States Assured Nursing Full time

    **Job Summary**Assured Nursing is seeking a skilled Diagnostic Imaging Professional to join our team as a Travel Imaging Specialist. This is a 13-week contract position in York, Maine.**Job Responsibilities**Operate and maintain imaging equipment, including CT scanners, to produce high-quality diagnostic images.Assist patients with positioning and...

  • Warehouse Order Fulfillment Specialist

    2 weeks ago

    Saco, Maine, United States Kenco Logistics Services, LLC Full time

    Job OverviewPosition SummaryThe Warehouse Picker/Packer Associate plays a crucial role in the logistics process by ensuring accurate order fulfillment. This position involves selecting and packing products for shipment, as well as performing quality checks to meet customer expectations.Key ResponsibilitiesAccurately pick products for shipment, verifying the...

  • Assembly Specialist

    2 days ago

    Saco, Maine, United States General Dynamics Ordnance and Tactical Systems Full time

    Job SummaryGeneral Dynamics Ordnance and Tactical Systems is seeking a skilled Assembly Specialist to join our team. As an Assembly Specialist, you will be responsible for assembling components into sub-assemblies and performing final assembly of aircraft and crew-served weapons.Key ResponsibilitiesAssembly and Final Assembly: Assemble components into...

  • HVAC/R Service and Installation Specialist

    2 weeks ago

    Saco, Maine, United States Richardson's Mechanical LLC Full time

    Job OverviewRichardson's Mechanical LLC is a reputable family-owned business experiencing significant growth due to our commitment to quality service and customer satisfaction. We prioritize integrity and transparency in our operations, ensuring our team members have the necessary tools and support to excel in their roles.We are currently seeking licensed...

  • Warehouse Order Fulfillment Specialist

    2 weeks ago

    Saco, Maine, United States Kenco Logistics Services, LLC Full time

    Job OverviewPosition SummaryThe Warehouse Picker/Packer Associate plays a crucial role in the logistics process by accurately selecting and packing customer orders. This position involves utilizing various equipment to ensure that products are prepared for shipping and receiving, meeting the demands of our clients.Key ResponsibilitiesAccurately pick items...

  • Firestopping Specialist

    1 week ago

    Saco, Maine, United States National Firestopping Solutions Full time

    Job SummaryWe are seeking a skilled Firestopping Specialist to join our team at National Firestopping Solutions. As a Firestopping Specialist, you will be responsible for installing firestopping systems to ensure the safety and compliance of our clients' facilities.Key ResponsibilitiesFirestopping Installation: Seal, label, and document all joints,...