Quality Systems Specialist

Northborough, MA, United States

The Quality Systems Specialist is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.

Tasks & Responsibilities

Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to:

Serve as an auditor for internal audits

Create and maintain internal audit schedule

Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits

Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team

Provide support during external audits including scheduling, hosting, preparing audit responses

Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process

Develops metrics and performs trend analysis of key QS areas such internal and external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management

Supports maintenance of the CAPA program

Serves as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actions

Ensures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods

Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities

Oversees completion and control of customer questionnaires and other customer-required documents

Initiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assigned

Supports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processes

Provides quality system training for the organization as needed

Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management

Ensures all work is performed and documented in accordance with GMP requirements and existing company policies and procedures

Qualifications

Minimum of 2-year degree in Quality, Regulatory, Business or related field; OR certificate in Regulatory Science or Medical Product Development plus 1 year of regulated industry work experience required

Desired:

4 year degree in Quality, Regulatory, Business or related field

ISO13485:2016 and/or ISO9001:2015 Auditor Certification

Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)

3+ years of quality/regulatory experience in medical device or related industry

1 year experience conducting investigations and root cause analysis for complex/advanced issues

Competencies

Ability to read, write, speak and understand the English language

Ability to communicate clearly by conveying and receiving ideas, information and direction effectively

Ability to demonstrate adequate job knowledge to deliver a world class performance

Ability to challenge oneself to consistently meet all goals and deadlines

Willingness to strive for excellence by producing work that is free of errors and mistakes

Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately

Commitment to making improvements company wide

Demonstrated competence using Microsoft Office

Comprehensive understanding of applicable cGMP requirements, including ISO standards, and FDA and other QS regulations

Comprehensive understanding of internal documentation (e.g., QS Manual, SOPs, etc.) and records and how they relate to cGMP requirements

Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques

Experience with metrics development and data analysis

Able to provide compliance guidance based on knowledge of regulations, available relevant information, alternatives, and risk

Able to perform math functions

Effective trainer and project leader

Good manual dexterity

Ability to maintain a professional and respectful relationship with coworkers and company representatives

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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