Quality Systems
1 month ago
Quality Systems & Compliance Manager
North Carolina - Kinston
Salary: $130k + 15% bonus
PTO: 20 days
Job Summary:
Lead global strategies for Supplier, Corporate Facility, and Third-Party audits, ensuring quality standards across business units.
Analyze Customer audits to identify improvement opportunities for West's systems and processes.
Essential Duties and Responsibilities:
- Manage all audit activities for Audit program, covering supplier, corporate facility, and third-party audits.
- Conduct corporate facility audits to ensure compliance with procedures and regulations.
- Audit suppliers to assess Quality Management System and compliance with quality standards.
- Develop and implement global strategies for standardised audit processes and tools.
- Manage post-audit activities, including corrective and preventive actions, and resolve conflicts.
Basic Qualifications:
- Bachelor's Degree in Engineering or related field required, Master's Degree preferred.
Work Experience:
- Minimum 8 years of related experience required.
Preferred Knowledge, Skills, and Abilities:
- Experience in regulated industries such as pharmaceutical and medical devices.
- Proficiency in cGMP, cGDP, relevant ISO standards, and medical device requirements.
- Familiarity with SAP systems and document management databases.
- Strong communication and interpersonal skills, including public speaking.
- Excellent organisational skills for planning, prioritisation, and goal achievement.
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