Sol-Millennium is a global healthcare company dedicated to improving the safety and well-being of patients and healthcare providers. With innovative solutions and a commitment to excellence, we strive to deliver products that enhance the quality of care. Our team is passionate, driven, and committed to making a difference in the healthcare industry.

Job Overview:

We are seeking a highly skilled and technically proficient Quality Assurance Manager (QA Manager) to join our team at Sol-Millennium. This role is crucial for ensuring that our products meet the highest standards of quality and compliance. Initially starting as an individual contributor, the successful candidate will build and lead a global team to collaborate with regulatory, sourcing, marketing, R&D, and other functions. This position will play a pivotal role in both maintaining and enhancing our quality management systems and procedures to support our new and existing product lines.

Key Responsibilities:

• Lead and manage all quality assurance activities, starting as an individual contributor and evolving to build and lead a global team.
• Collaborate with cross-functional teams to ensure product quality and compliance with all relevant regulations and standards.
• Develop and implement quality strategies and processes to improve product quality and operational efficiency.
• Conduct supplier and product qualifications, ensuring compliance with 21 CFR 820, 21 CFR 210/211, and EU MDR.
• Perform lead auditor responsibilities for ISO 13485 vendor audits.
• Travel up to 50% of the time, including visits to vendors and facilities

Minimum Qualifications:

• Bachelor’s degree in Engineering.
• Minimum of 6 years of quality experience, with at least 2 years in a management role.
• At least 4 years of experience working in a manufacturing environment.
• Strong sense of urgency, excellent decision-making skills, and proven leadership abilities.
• Willingness to travel up to 50% of the time.

Preferred Qualifications:

• Experience with Lean/Six Sigma concepts, with a focus on revamping existing procedures.
• Experience with product development activities such as DHF, DMR, FMEA, and CE Tech files for sterile products.
• Lead auditor certification in ISO 13485.
• Bilingual in English and Spanish.
• Experience with global teams and demonstrated ability to work collaboratively with internal and external stakeholders.

Critical Skills:

• Excellent problem-solving skills.
• Highly capable of independently making decisions based on quality data and regulatory requirements.
• Exceptional ability to organize and prioritize ongoing projects.

About Sol-Millennium:

We are a global healthcare company dedicated to building a healthier tomorrow through the development, manufacture, and distribution of high-quality medical devices.

Visit our "About Us" page to learn more! https://naca.sol-m.com/about⠀

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This job description is not intended to encompass all duties that may be required. Additional responsibilities in line with the original scope of work may arise as the business evolves.

Sol-Millennium is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business need.