Quality Director

About the role

We are responsible for ensuring that our products meet the highest standards of quality and safety. This includes overseeing compliance with FDA regulations and international standards.

Responsibilities

• Develop and implement quality management systems aligned with FDA and ISO standards.
• Oversee the quality assurance process, including audits and inspections.
• Ensure adherence to budget, schedule, and performance requirements.
• Manage and mentor a team of quality professionals.
• Contribute to the development and implementation of business strategies and plans.
• Interact with executive-level management to negotiate critical matters.

Requirements

• Minimum Bachelor’s degree in Science, Engineering, or a related field.
• Minimum 10+ years of relevant supervisory experience.
• Proven ability to manage multiple tasks and drive execution of organizational objectives.
• Strong leadership skills, including the ability to motivate and develop high-potential associates.
• Excellent communication and interpersonal skills, including the ability to influence and negotiate with executives.
• Sound knowledge of FDA 21 CFR 820 and ISO 13485:2003.

Qualifications

• Ability to effectively manage multiple tasks and drive execution of organizational objectives and strategies.
• Ability to lead a management team in managing subordinates and executing organizational objectives and/or strategies.
• Ability to effectively write communications that ensure clarity, accuracy, and consideration of the audience.
• Ability to speak with clarity and express points of view in a variety of settings.
• Ability to listen to others and identify and develop high-potential associates.
• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution.
• Solid understanding of FDA 21 CFR 820 and ISO 13485:2003.

Skills

• Strategic thinking and problem-solving skills.
• Strong leadership and mentoring abilities.
• Effective written and verbal communication skills.
• Ability to influence and negotiate with executive-level management.
• Knowledge of FDA regulations and ISO standards.

Benefits

BD offers a comprehensive benefits package including health insurance, retirement plans, and paid time off.

Pay

$163,000.00 - $293,300.00 USD Annual

Schedule

Full-time position