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Lead Quality Assurance Strategist
2 months ago
Company: United Imaging North America
Position: Senior Quality Manager
Location: Houston, TX
About Us:
United Imaging North America is a prominent global innovator in medical devices, specializing in advanced imaging technologies and healthcare IT solutions. Our mission is to enhance patient care worldwide through cutting-edge technology and a dedicated workforce. We are committed to fostering a collaborative environment where talented professionals can thrive and advance their careers.
Role Summary:
We are seeking a full-time Senior Quality Manager who possesses the ability to engage effectively with team members in a dynamic setting. This role demands a proactive, resourceful, and efficient individual who maintains a high standard of professionalism and confidentiality.
Compensation and Benefits:
We offer a comprehensive benefits package, including medical, dental, and vision coverage, short- and long-term disability insurance, an employee assistance program, company-paid life insurance, a 401(k) plan with employer matching, paid time off, sick leave, and eleven paid holidays. Compensation is determined based on skills, qualifications, geographical location, and experience, with potential for performance-based incentives.
Diversity and Inclusion:
United Imaging is an Equal Opportunity Employer. We value diversity, equity, and inclusion and provide equal employment opportunities to all applicants, prohibiting discrimination and harassment of any kind.
Key Responsibilities:
Quality Management:
- Develop and implement quality standards, management systems, and policies.
- Lead the Quality Management System to ensure continuous improvement, including documentation maintenance.
- Report to senior management on quality system performance and improvement areas.
- Promote compliance with customer quality requirements and regulatory standards across the organization.
- Drive local quality objectives and participate in global quality initiatives.
- Ensure the effectiveness of the Quality Management System through regular reviews.
- Manage quality-related audits and analyze results to implement necessary actions.
- Conduct training sessions on quality assurance for all employees.
- Oversee the non-conformance and corrective action processes.
- Support engineering departments in quality-related matters.
- Encourage a process-oriented and risk-based approach throughout the organization.
Environmental Health & Safety:
Manage the Environmental Health & Safety (EHS) program, conduct internal audits, and represent the company during external audits. Maintain reporting and audit records, manage PPE requirements, and collaborate with HR and management to enhance the EHS culture.
Qualifications:
- Bachelor's degree in engineering, science, or a related field.
- Minimum of two years of quality engineering experience in medical devices or related industries.
- Familiarity with FDA medical device regulations is required; RSO certification is preferred.
- Experience in project management is a plus.
- Strong auditing skills and knowledge of Quality Management Systems (ISO 13485:2016, 21 CFR 820).
- Proficient in Microsoft Office applications.
- Knowledge of EHS regulations is essential.
- Experience in a production environment is required.
Skills:
- Excellent multitasking and organizational abilities.
- Strong analytical and problem-solving skills.
- Effective communication skills, both written and verbal.
- Ability to work independently and as part of a team.
- Proven leadership capabilities to motivate and influence others.
We Offer:
A competitive benefits package, including medical, dental, vision, and paid time off, along with the opportunity to be part of a growing organization with a unique culture.
