Job Description
Our Medical Device Client combines the backing of a Fortune 20 company with the dynamic, collaborative energy of a growing startup. As a Quality Compliance Specialist, you will play a critical role in maintaining compliance and supporting quality systems as we expand in-house manufacturing and packaging operations. This position offers the opportunity to work closely with a tight-knit team while leveraging advanced tools and processes to ensure regulatory and quality standards are met.
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.
QUALIFICATIONS
- Education: Bachelor’s degree in technology, science, or engineering (required).
- Experience: Minimum 3+ years in a quality compliance or related role within a regulated industry (medical device experience preferred).
- Strong knowledge of quality systems, document control, and audit processes.
- Technical Skills:
- ComplianceWire (required)
- ETQ (required)
- Advanced Excel skills for data analysis and reporting
- Oracle ERP (nice to have)
- Certifications (preferred):
- Six Sigma
- ASQ Quality Auditor or ASQ Quality Engineer
- Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.