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Quality Assurance Specialist

in Chelmsford, MA

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Job Description Job Attributes+

  • Req. ID

    R4482

  • Organization

    Semiconductor

  • Job Category

    Engineering

  • Job Type

    Full time

  • Job Location

    15 Elizabeth Drive
    Chelmsford, MA 01824
    US

Overview

Brooks Life Sciences is seeking a Quality Assurance Specialist to provide leadership and quality-oriented focus in identifying, establishing, planning, implementing, maintaining and administering Quality Management System Requirements within the business and, as necessary, with our customers and suppliers, to meet quality objectives.

Teambuilding and stakeholder analysis in this position is critical (i.e. motivate a lot of people that do not report to you).

Ensure compliance with medical device regulatory standards, FDA Quality System Regulation (QSR), aware of Medical Device Regulation (MDR), and expert on ISO 9001:2015 and ISO 13485:2016 and equivalent-international regulations through the development process and ongoing quality/regulatory compliance in manufacturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:

  • Assist in developing a vision for the Quality organization and translate that into operating plans and actions to ensure complete customer satisfaction and financially sound business growth.
  • With guidance from management, assist with regulatory submissions, including 510(k) and CE Marking, Investigational Device Exemption (IDE), and other applications (i.e. Premarket Approval Applications (PMA)) as applicable.
  • Provide quality guidance and expertise as a member of the product development team including Design Controls, design and process validation, risk management, sterilization validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files.
  • Perform labeling reviews and approvals for quality and regulation compliance.
  • Participate in Internal Quality Audit program, including interfacing with international manufacturing sites, and in third party audits (FDA, Notified Body) of the Quality System .
  • Support activities within the corporate Quality Management System (QMS) and Good Manufacturing Practices (GMPs).
  • Develop and provide internal training on regulatory and quality.
  • Perform routine audits to ensure Quality and Manufacturing Departments are complaint with all Work Instructions, SOPs, Control Plans, etc.
  • Ensure the quality of all products produced for commercial distribution domestically and internationally.
  • Establish and implement quality plans and systems for new product approval/clearance and ensure ongoing operational and quality compliance.
  • Establish and complete new product / existing product manufacturing and quality engineering activities (e.g., process risk analyses, process validations, sampling plans, statistical process control (SPC), supplier qualifications, and training compliance).
  • Work with product development teams and suppliers by identifying and implementing quality process improvements for efficiency and effectiveness and providing prompt investigation and action for non-conformances in manufacturing.
  • Propose and maintain timelines for submissions and compliance activities based upon company goals, product development, regulatory strategies and applicable federal and state regulations.
  • Assist management with ongoing quality improvement initiatives.
  • Interface with quality representatives from suppliers and customers and develop corrective action plans for effective implementation.
  • Stay abreast of current applicable testing and regulatory standards, guidance documents and industry working groups.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Strong working knowledge of medical device regulatory requirements, including FDA 21 CFR 820, MDR, and ISO 13485:2016 and medical device recognized standards (e.g., sterilization validation).
  • Candidate must be highly motivated and passionate about developing new products with strong documentation, oral, and interpersonal communication skills required.
  • Must be proficient in the use of personal computers to include word processing, spreadsheets, and databases. Must be exacting in handling detailed information/data.
  • Strong analytical and statistical skills.
  • Experience in First- and Second-Party auditing is highly desirable.
  • Quality Auditor, or a Certified Lead ISO Auditor.
  • System Software experience including Microsoft Office Products and ERP/MRP systems
  • Proficient with virtual meetings and virtual audits
  • Certification in an applicable Quality field (i.e. Certified Quality Engineer, Certified Quality Auditor, or a Certified Lead ISO Auditor) is preferred.

EDUCATION AND/OR EXPERIENCE

  • A Bachelor's degree in manufacturing engineering, quality engineering, or related field
  • 5+ years' experience in quality assurance is required; 10+ years’ experience preferred
     

EOE M/F/Disabled/VET

JOB LOCATION

15 Elizabeth Drive
Chelmsford, MA  01824

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