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Brooksource · 3 weeks ago

Quality Compliance Specialist

New Brighton, MN

Full-time

Hybrid

Mid Level

$35/hr - $47/hr

3+ years exp

Brooksource is supporting a Medical Device Client that combines the backing of a Fortune 20 company with the dynamic energy of a growing startup. As a Quality Compliance Specialist, you will play a critical role in maintaining compliance and supporting quality systems during the expansion of in-house manufacturing and packaging operations.

EmploymentHuman ResourcesInformation Technology

Growth Opportunities

Responsibilities

Provide audit support, including preparation and follow-up for internal and external audits

Assist with management review activities and reporting

Oversee document and change control processes to ensure compliance with company and regulatory requirements

Conduct quality investigations and support root cause analysis for nonconformances

Perform DHF (Design History File) audits to verify documentation accuracy and completeness

Execute standard gap assessments to identify compliance risks and improvement opportunities

Collaborate with cross-functional teams to maintain and improve quality systems

Qualification

Quality systemsDocument controlAudit processesComplianceWireETQAdvanced ExcelOracle ERPSix SigmaASQ Quality AuditorASQ Quality EngineerManage prioritiesAttention to detailOrganizational skills