Quality Assurance Engineer jobs in Lawrence, MA

Quality Assurance Engineer performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products. Assists in developing quality control policies and evaluates production limitations. Being a Quality Assurance Engineer requires a bachelor's degree. Typically reports to a supervisor or manager. To be a Quality Assurance Engineer typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)

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Quality Assurance Engineer
  • QIAGEN
  • Beverly, MA FULL_TIME
  • Overview

    At the heart of QIAGEN's business is a vision to make improvements in life possible.

    We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
    Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
    There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
    If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

    Join us. At QIAGEN, you make a difference every day.

    Position Description

    This position will report to the Quality Assurance Manager. S/he represents Quality within cross-functional teams to coordinate documentation and ensure compliance for instrument IQ/OQ, assay Verification/Validation activities and Risk Management. Position responsibilities also include monitoring Engineering Change Controls and data trending to provide corrective action solutions that drive continuous improvement.

    Job performance will involve a variety of activities including:

    - Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.

    - Support the creation and the maintenance of Risk Management plans including dFMEAs, pFMEAs and Control Plans.

    - Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.

    - Conduct and support investigations of manufacturing nonconformities, recommend, develop and implement effective corrective actions.

    - Conduct and support complaint handling activities such as intake, evaluation, investigations and reporting.

    - Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems.

    - Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics

    - Participates on audits conducted by regulatory agencies and/or customers.

    - Participates in supplier evaluation and selection assessments.

    - Maintains a working knowledge of industry standards. Knows and follows the ISO quality system guidelines.

    - Performs external vendor audits to ensure ISO and/or FDA compliance.

    - Additional responsibilities may be assigned as needed.

    Position Requirements

    - Between 2-4 years of overall QA experience in an ISO and/or FDA regulated environment, with at least 2 years in direct QE role.

    - Bachelor's degree preferably in a life science discipline, or equivalent experience.

    - Experience with ISO 13485 certification, (FDA 21CFR 820 and 21CFR Part 11 also desired).

    - Experience with Risk Management per ISO 14971:2019 desired.

    - Experience in a Good Manufacturing Practice (GMP) environment.

    - ASQ certified Quality Auditor and/or Quality Engineer - CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable.

    Personal Requirements

    - Attention to detail

    - Drive and Determination

    - Positive external and internal relationship management skills

    - Ability to participate with other members of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company

    - Proven ability to thrive in a change oriented environment

    - Must be proficient in MS Office (Outlook, Teams, Word, Excel, PowerPoint)

    What we offer

    At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

    QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

    QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact . This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.


    We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

     

  • 15 Days Ago

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Sr. Engineer, Design Quality Assurance
  • Fresenius Medical Care
  • Lawrence, MA FULL_TIME
  • PURPOSE AND SCOPEParticipate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control ...
  • 4 Days Ago

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Quality Assurance Specialist
  • Axiomtek
  • Methuen, MA FULL_TIME
  • JOB BRIEF The position QA Specialist manages and maintains the database for the quality management system, prepares and presents quality trending reports, provides input to QA Manager and/or Team Lead...
  • 19 Days Ago

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Quality assurance specialist
  • Pioneer Data Systems
  • Andover, MA FULL_TIME
  • Position Details : Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Quality Assurance Specialist to join their expanding team. Job Title : Quality Assurance...
  • 21 Days Ago

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Quality Assurance - Clinical
  • pfizer
  • Andover, MA FULL_TIME
  • Quality Assurance Specialist - 2 OpeningsSummary:The Quality Assurance Specialist will support the QA QC/Site team with the review and approval of various documents for drug substance testing (SOPs, m...
  • 23 Days Ago

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Quality Assurance Validation Specialist
  • pfizer
  • Andover, MA FULL_TIME
  • Quality Assurance Validation SpecialistSummary: The individual will provide Quality Assurance oversight in support of various day-to-day standard review work. The individual will be responsible for th...
  • 24 Days Ago

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0 Quality Assurance Engineer jobs found in Lawrence, MA area

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Quality Assurance
  • State Street Corporation
  • Boston, MA
  • Quality Assurance (State Street Bank and Trust Company; Boston, MA): Will serve the Company by testing software for adva...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Engineer II
  • Katalyst Healthcares & Life Sciences
  • Acton, MA
  • Responsibilities: Review individual complaints and associated service data to determine risk level and complete investig...
  • 3/28/2024 12:00:00 AM

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Senior Quality Assurance Engineer
  • Katalyst Healthcares & Life Sciences
  • Westborough, MA
  • Responsibilities: Interface with customers in various forms of communications including regional forums and specific cus...
  • 3/28/2024 12:00:00 AM

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Co-Op, Design Quality Assurance Engineering (Remote/Flexible)
  • Insulet Corporation
  • Acton, MA
  • Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier li...
  • 3/28/2024 12:00:00 AM

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Expression of Interest: QA Engineer
  • Fingerprint For Success
  • Boston, MA
  • We are inviting professionals in high-growth industries who are thinking about their next move or looking for a new oppo...
  • 3/28/2024 12:00:00 AM

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Software Quality Assurance Manager
  • Cy9
  • Acton, MA
  • Lead and manage the embedded Software Quality assurance team ensure Software verification is conducted in accordance to ...
  • 3/28/2024 12:00:00 AM

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Manufacturing Quality Assurance Engineer
  • DEKA Research & Development
  • Manchester, NH
  • Join our onsite dynamic team at DEKA and be at the forefront of driving quality excellence! As our Manufacturing QA Engi...
  • 3/25/2024 12:00:00 AM

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Quality Assurance Engineer II
  • Katalyst HealthCares and Life Sciences
  • Acton, MA
  • Responsibilities: Review individual complaints and associated service data to determine risk level and complete investig...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the city has a total area of 7.4 square miles (19 km2), of which 7.0 square miles (18 km2) is land and 0.4 square miles (1.0 km2) (6.07%) is water. Lawrence is on both sides of the Merrimack River, approximately 26 miles (42 km) upstream from the Atlantic Ocean. On the north side of the river, it is surrounded by Methuen. On the south side of the river, the town is bordered by North Andover to the east, and Andover to the south and southwest. Lawrence is approximately 30 miles (48 km) north-northwest of Boston and 27 miles (43 km) southeast of Manc...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineer jobs
$71,401 to $88,628
Lawrence, Massachusetts area prices
were up 1.6% from a year ago

Quality Assurance Engineer in Cleveland, OH
Technically supervises quality projects or major phases of significant quality projects, coordinating the efforts of technical support staff in the performance of assigned project.
November 16, 2019
Quality Assurance Engineer in Altoona, PA
SQA Engineers develop and execute software test plans in order to identify software problems and their causes.
November 08, 2019
Quality Assurance Engineer in Tulsa, OK
An entry level role, the degreed Engineer knows and applies basic concepts and techniques of the profession under direct supervision and guidance.
November 01, 2019