Senior Quality Systems Specialist I

Werfen•Bedford, MA

2d•Hybrid

About The Position

Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager. This position is located out of our Bedford, MA facilities and the anticipated work set up is 4 days onsite and 1 day remote.

Requirements

Attention to Detail: Good ability to pay close attention to detail is required
Accuracy: Work is accurate and completeness of records
Outstanding Performance Standards: Demonstrated good ability to meet department goals
Ethics and Values: Integrity and Trust / Ability to be Discrete
Delivery of Results (Action Orientation): Good ability to Learn on the Fly / Taking Initiative
Communication: Good written and verbal communication skills
Discretion: Acts Honest, Loyal, Trustworthy
Multi-Tasking: Good planning, organizational and time management skills are required to support changing business needs
Collaboration: Good ability to work with cross functional teams
Independence: Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team
Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
Takes Initiative: Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence
Problem Solving: Good problem-solving skills are required
Previous Quality Assurance experience within a GMP regulated environment required.
Good understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation.
Good computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required.
Good understanding of change control requirements.
Good understanding of record retention.
Bachelor's degree or equivalent in engineering or science
A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 5 years of experience with an advanced degree
Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering
Understanding of the application of technical principles and engineering problem solving to resolve complex issues.

Nice To Haves

ASQ Quality Engineering Certification - Desirable
LEAN/Six Sigma Certification - Desirable

Responsibilities

CAPA process – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
Internal Audit program – planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
Quality Agreements – maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
Quality Plans – issuing number, creating plan, tracking status, timely/appropriate closure
External Documents – tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans.
Management Review – Support the creation and delivery of the Management Review presentation. Support completion and approval of the Management Review Meeting Minutes and closure of Action Items.
Training program – focusing on improving the competencies of personnel to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed.
Facilitates meetings related to QS activities
Supports change orders/process improvements with respect to Quality Management System procedures with direction from management
Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
Participates in internal, external (including regulatory) and/or 3rd party audits, as needed
Carries out duties in compliance with established business policies
Provides assistance and recommendations based on a clear understanding and implementation of regulatory standards
Interfaces with all functions and levels of management as needed
Other duties as assigned, according to the changing needs of the business