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Sr. Quality Specialist

Company: Draeger Medical Systems, Inc.
Location: Andover
Posted on: June 26, 2022

Job Description:

The Job Responsibilities

Provide guidance, support, and mentorship to CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools. Provide CAPA metrics and reporting on critical aspects regarding the health of the CAPA process.
Maintain compliance and continuously improve the QMS regarding ISO 9001, ISO 13485, and CFR 21 and further regulatory requirements which apply to the facility. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Support the development and implementation of Quality System procedures, software, and training programs. Prepares reports and/or necessary documentation (ex: Corrective and Preventative Actions, Training reports, Metrics) and provides to applicable stakeholders, both internal and external.
Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Develop and implement quality metrics to drive improvements and business results. Work collaboratively with business teams to track efficacy of actions taken.
Responsible for the administration of the quality system, including implementation and maintenance to regulatory requirements and standards, such as applicable ISO standards.
This person must be able to lead the end to end process of the QMS, including utilization of the database systems used to support the Quality system. Support all third-party inspections and audits (NB, FDA, etc).
Ensure and promote a world-class quality mindset via a robust training and quality system strategy. Facilitate a DMSI training and quality systems policy including standard workflows and Profiles to support the policy, champion QMS training process as assigned including development of key trainings and deployment.
Performs other duties as needed and assigned.

Your Qualifications


BS in related technical discipline.

Related Experience:

5-7 years of medical device product experience related product development and Quality System Management.
Strong working knowledge of risk management and design controls for medical device products.
Skilled in test plan development and root cause failure analysis.
Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 9001, ISO 13485, MDR
Must possess effective written, verbal and presentation skills; strong influencing skills at all levels.
Certified Quality Engineering and/or Certified Software Quality Engineering certificate desired
Familiarity with data analytics development and deployment

Keywords: Draeger Medical Systems, Inc., Boston , Sr. Quality Specialist, Other , Andover, Massachusetts

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