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We are seeking a highly experienced Senior Quality Assurance Manager to join our team at SENIOR SPIRIT OF ROSELLE PARK. As a key member of our Global Quality team, you will be responsible for ensuring the highest standards of quality in our operations and products.
Key Responsibilities- Develop and implement quality systems and processes to ensure compliance with regulatory requirements and industry standards.
- Lead the development and maintenance of quality management systems, including quality policies, procedures, and training programs.
- Collaborate with cross-functional teams to identify and mitigate quality risks, and implement corrective actions as needed.
- Conduct audits and assessments to ensure compliance with quality standards and regulatory requirements.
- Develop and implement quality metrics and reporting to track performance and identify areas for improvement.
- Provide guidance and support to site quality teams to ensure consistent application of quality standards and procedures.
- Minimum 10 years of experience in quality assurance, with 7 years in the healthcare industry.
- Proven experience in managing client and regulatory inspections, negotiating client contracts, and providing clear traceability of client-specific requirements.
- Strong knowledge of quality tools, including FMEA, QCP, 8D, and 3x5why.
- Ability to articulate and explain methodologies related to process control, including SPC and Ppk.
- Excellent interpersonal and communication skills, with the ability to interact effectively with various stakeholders.
- Strong analytical and problem-solving skills, with the ability to review data, formulate written analysis, and identify areas for improvement.
- Certified Lead Auditor to ISO13485, with a proven record of auditing global suppliers.
- Experience in auditing to VDA6.3 standard.
- Knowledge of international standards, including ISO9001, IATF 16949, and 21 CFR part 820.
- 6 Sigma DMAIC Black Belt certification.
Senior Spirit of Roselle Park is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions. We are committed to delivering high-quality products and services to our customers, and we are seeking a highly experienced Senior Quality Assurance Manager to join our team.
