Quality Systems Specialist

About the role

The Quality Systems Specialist role supports the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory requirements. This includes supporting audit readiness activities, QMS processes, and continuous improvement initiatives.

Responsibilities

• Support the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance.
• Interpret and apply internal policies, regulatory, and governmental requirements with guidance from quality leadership.
• Collaborate with cross-functional teams to perform process analysis and support adherence to applicable regulations.
• Support internal and external audit and inspection activities, including audit preparation, documentation, response coordination, and follow-up of observations.
• Aid as a point of contact during audits and inspections, ensuring timely communication and document retrieval.
• Prepare quality reports, metrics, and documentation, including CAPAs and quality records.
• Support requests related to regulatory, legal, or compliance matters as needed.
• Maintain and update quality assurance programs, procedures, and policies.
• Participate in continuous improvement initiatives and promote best practice sharing across functions.

Qualifications

• Minimum Requirements: Bachelor’s Degree AND a minimum of 2 years of relevant experience, OR an advanced degree with 0 years of relevant experience.
• Nice to Have: 2+ years of experience with FDA 21 CFR Part 820 and ISO 13485, experience supporting internal and external audits, knowledge of CAPA, nonconformance, change control, and document control processes, familiarity with Lean, Six Sigma, or continuous improvement methodologies, familiarity with MDSAP, experience with quality systems software such as TrackWise (Sparta), experience with PLM systems such as Agile or Windchill, experience with SAP QM or other ERP quality management modules.

Skills

• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with quality systems software such as TrackWise (Sparta).
• Experience with PLM systems such as Agile or Windchill.
• Experience with SAP QM or other ERP quality management modules.

Benefits

Competitive Salary and flexible Benefits Package including:

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)

Pay

$75,200.00 - $112,800.00 USD

Schedule

Full-time