Director of Quality

Founded in 2005 to fulfill high customer demand for Fulfillment and Contract Assembly Services work in Salt Lake City, Nimbl Fulfillment and Assembly has grown to be one of the premium full-service fulfillment and assembly companies in the United States. Poised for substantial growth, Nimbl manufactures and fulfills products on-site in a state-of-the-art, eco-friendly facility in Salt Lake City.

Are you an experienced and hands-on Senior Manager or Director of Quality with a Medical Device or Pharmaceutical Manufacturing background? Have you previously managed a Quality Control team that effectively establishes and maintains Quality Management System (QMS) requirements? If so, we seek a meticulous, passionate leader to elevate our quality management system. Reporting to the General Manager, the Director of Quality will directly oversee the development and implementation of the company-wide QMS and all its components for a medical device manufacturer.

Key Responsibilities:

• Quality Management System Advancement: Spearhead the implementation and continuous enhancement of the Quality Management System (QMS) in alignment with ISO 13485 and other pertinent standards, ensuring adherence to best practices that elevate organizational quality.
• Leadership Excellence: Lead and nurture a high-performing quality team, fostering an environment of professional development and motivation that empowers employees to excel in their roles.
• Collaborative Engagement: Foster effective collaboration with cross-functional teams to uphold compliance and drive continuous improvement. Create a supportive and cooperative culture that prioritizes quality, moving away from a merely regulatory framework to one that inspires collective ownership of quality standards.
• Audit Leadership: Direct both internal and external audit activities to uphold ISO 13485, MDSAP, and MDR certifications. Ensure our standards of compliance are not only met but exceeded.
• Supplier Quality Oversight: Manage comprehensive supplier quality initiatives, including conducting audits, qualifying suppliers, and monitoring performance to guarantee that supplier contributions meet our rigorous quality standards.
• NCR/CAPA Management: Oversee the nonconforming material control process and the Corrective and Preventive Action (CAPA) protocols, encompassing thorough investigations, root cause analysis, and the implementation of effective corrective measures.
• Training Development: Design and implement impactful training programs that educate personnel on Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), regulatory compliance, and company standards, enhancing the organization's overall quality competency.
• Batch Record Oversight: Supervise the batch record review process, ensuring meticulous attention to detail and compliance with quality expectations.
• Key Performance Indicators (KPIs) and Quality Metrics: Monitor critical quality performance indicators (KPIs) to assess the QMS’s effectiveness and pinpoint enhancement opportunities, driving a continuous improvement culture.
• Customer Complaint Management: Lead the investigation and resolution of customer complaints, ensuring comprehensive documentation and compliance with regulatory requirements, enhancing customer satisfaction and trust.
• Document Control Administration: Ensure robust documentation control and record-keeping practices that align with regulatory standards. Manage Engineering Change Orders (ECOs) and oversee post-implementation assessments to guarantee adherence to established procedures.

Requirements:

• A Bachelor of Science degree in a technical or scientific discipline is required.
• A minimum of 5 years of experience in quality management within the medical device industry.
• In-depth knowledge of ISO 13485, ISO 9001, FDA regulations, and other relevant standards.
• Certification in quality management (e.g., CQE, CQA) is a plus.
• Versatility and flexibility, with a willingness to work enthusiastically within constantly changing priorities.
• Good judgment with the ability to make timely and sound decisions.
• Commitment to excellence and maintaining high standards.
• Strong problem analysis and resolution skills at both strategic and functional levels.
• Strong leadership and interpersonal skills.
• Excellent written and verbal communication skills, with the ability to convey complex concepts effectively.
• Demonstrated ability to manage multiple priorities and tasks and efficiently resolve variances.
• Must be able to work in a production area with moderate to high noise levels for extended periods.
• Must be able to frequently stand, walk, bend, kneel, crouch, balance, and reach.
• Regularly required to lift and/or move items weighing up to 50 lbs.

Compensation and Benefits:

• Medical, Dental, and Vision coverage available on the first of the month following 30 days of employment.
• 401K plan and company-sponsored Life Insurance.
• 3 weeks of PTO 6 Paid Holidays (Accrued and pro-rated based on your date of hire).
• Highly competitive Base Pay plus Bonus based on success in achieving individual and company goals.
• Nimbl Fulfillment is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, ancestry, gender, gender identity and/or expression, genetic information, veteran status, disability, citizenship status, marital status, pregnancy, or any other characteristic protected by federal, state, or local employment discrimination laws.