Quality Systems Specialist
About The Position
In this role as a Quality Systems Specialist, you will support the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory requirements. You will assist in audit readiness activities, support Quality Management System (QMS) processes, and contribute to continuous improvement initiatives. You will support internal and external audits, including FDA inspections, Notified Body audits, and other regulatory inspections, helping to maintain a state of inspection readiness and compliance. The Quality Systems Specialist supports the development, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and company requirements. This role partners with cross-functional teams to support audits and inspections, CAPA and compliance activities, Quality Management Reviews, Operations Quality Walks, SAP QM administration, and quality system improvement initiatives while helping maintain a state of inspection readiness and regulatory compliance.
Requirements
- Bachelor’s Degree AND a minimum of 2 years of relevant experience, OR an advanced degree with at 0 years of relevant experience.
Nice To Haves
- 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 Medical Device Single Audit Program (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.
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.
- Assist 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.
- Support the Quality Management System by assisting with implementation and maintenance of regulatory requirements, including but not limited to FDA 21 CFR Part 820, ISO 13485, and applicable company procedures.
- Support QMS harmonization efforts and compliance activities.
- Coordinate and support internal and external audits and inspections by assisting with planning, document collection, audit logistics, and follow-up activities.
- Support inspection readiness efforts through routine assessments and compliance monitoring.
- Manage the OQW program by coordinating routine floor assessments against established criteria.
- Identify compliance gaps, track corrective actions, partner with cross-functional teams to drive accountability, and ensure timely follow-up and continuous improvement activities.
- Manage SAP QM Local Data Administrator (LDA) activities, including support for material master data, inspection setup, and quality-related system configurations to ensure data integrity and compliance.
- Utilize structured problem-solving tools, root cause analysis, and continuous improvement methodologies to identify and address quality issues and improve business processes.
- Support quality system projects and collaborate with cross-functional teams to achieve project objectives.
- Contribute ideas and recommendations for process improvements and compliance enhancements.
- Support Quality Management Review (QMR) activities by ensuring accurate data inputs, preparing reports, and facilitating discussions to drive compliance and continuous improvement at the leadership level.
Benefits
- 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)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
