Quality Systems Specialist

UFP Technologies • Newburyport, MA

5d • Onsite

About The Position

The Quality Systems Specialist will provide quality systems support to Quality, Manufacturing, and R&D Engineers in QMS improvements, corrective and preventive actions, customer complaints, general project management and audits. This position will support process and planning decisions with knowledge of Quality System policies, practices, procedures, standards and regulations.

Requirements

• Bachelor’s degree in Quality Assurance, Engineering, or Technology and 5 years of experience in a quality systems or manufacturing environment in regulated environment (medical device preferred) or equivalent combination of education and experience.
• Experience with 21 CFR Part 820 and ISO 13485.
• Experience participating in external / internal audits.
• CAPA resolution expertise.
• Experienced at writing technical documents.
• Occasional travel may be required.

Nice To Haves

• Project Management experience (preferred).

Responsibilities

• Oversees the development and maintenance of quality systems programs, processes and procedures, ensuring compliance with policies and established regulatory standards.
• Participates in internal / external quality audits, prepares audit reports, initiates CAPAs or other activities as necessary.
• Provides expertise, guidance, and leads non-conformance and CAPA action plans to ensure key performance indicators are met.
• Accountable for customer complaints process to ensure complaints are addressed in an efficient and timely manner.
• Participates in continuous improvement initiatives within both the Quality Department and the Plant as a whole.
• Oversees and controls processes for handling non-conforming and returned products.
• Oversees rework is performed by following appropriate procedures and their documentation.
• Writes and updates procedures to support corrective actions.
• Collaborates cross-functionally to drive corrective actions to improve metrics. Reviews any outstanding CAPAs with management.
• Collaborates cross-functionally on complaint trend monitoring, evaluation, and investigation of signals and potential trends.
• Educates employees on Quality Management System Processes and compliance.
• Provides project management support.
• Participates in conducting both internal and vendor audits.
• Performs other similar duties as required by responsibility, necessity or as requested.

Benefits

• Medical, Dental, Vision, Life, Disability Insurance
• 401K with a matching contribution
• Paid time off, Paid holidays, Employee discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees