| Location: Onsite Status Type: Full Time QUALIFICATIONS Required: - Bachelor’s Degree in Scientific discipline
- Minimum of 7 years of GXP experience
- Minimum of 5 years of experience in the medical device or pharmaceutical industries
Preferred: - Certified Quality Auditor (CQA)
- Six Sigma or Project Management Professional certification is a plus
Skills & Competencies: - Ability to lead quality systems group by providing daily direction, resource planning, and develop longer term strategies
- Establish departmental metrics and goals in support of organizational strategic goals
- Prefer SAP experience
- Strong knowledge of medical device manufacturing systems and methods
- Strong ability to collaborate cross-functionally
- Knowledgeable in implementing and managing Quality Assurance systems and procedures
- Familiar with medical device manufacturing systems and methods
- Possess a good balance of technical experience, analytical thinking, and communication skills for resolving issues internal and external to the organization
- Competent with word processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab)
Physical Requirements: - Must be able to remain in a stationary position for extended periods of time
- Must be able to gown to access the controlled areas
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
RESPONSIBILITIES: - Manage several Quality system processes: documentation system, archive, change control, internal audit, training, and audit support
- Lead and support process improvement & efficiency projects, as necessary
- Able to lead audit teams to support external customers, regulatory bodies, and notified body audits. Responsible for developing and submitting responses
- Implementation and maintenance of requirements needed to conform to ISO 13485, CFR 820, and MDR
- Review/approval for Quality procedures and records
- Reporting routine Quality metrics to the Senior Management team
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