Quality Systems Manager

Job Summary

In this role you will manage the Quality Systems group which includes quality and customer projects as needed. This position will support supervision of document control personnel and activities depending on the departmental needs. This role may also support corporate internal customer and regulatory audits and with customer notification of changes. Improve the Quality Systems ensure compliance with our policies procedures and regulations and perform activities that will improve overall customer satisfaction. Develop the infrastructure for the Quality Systems function aligning with the strategic plan for Quality and for the Global West business. Ensure that the Quality System is current and meets the needs of the customer base and the applicable Regulatory bodies and Quality Standards such as 21 CFR Part 820 ISO 13485 and EU/MDR Requirements.

Essential Duties and Responsibilities

• Lead manage and develop the Quality Systems team by establishing clear goals providing regular performance feedback and supporting professional growth and development plans.
• Oversee and as needed review or approve investigations related to QMS elements such as audit findings nonconformances (NCRs) CAPAs and issue reviews.
• Support the execution of quality strategic plans and policies for the Scottsdale site in alignment with corporate objectives.
• Lead or participate in remediation and improvement initiatives that enhance the effectiveness and compliance of the Quality Management System.
• Participate in investigations and corrective actions stemming from QMS audits or other continuous improvement activities.
• Develop implement and deliver training programs related to QMS processes compliance and quality system improvements.
• Identify evaluate and implement process improvements across QMS elementsincluding Document Control Audits CAPA NCR Deviation Management Site QA KPIs and Management Review.
• Prepare for and lead customer corporate and regulatory audits to ensure robust audit readiness and compliance.
• Build and sustain a strong culture of quality through effective leadership coaching and cross-functional collaboration.
• Monitor and maintain compliance with global quality and regulatory standards including 21 CFR Part 820 ISO 13485 and EU MDR.
• Establish track and analyze Quality Metrics to assess system performance compliance and opportunities for improvement.
• Ensure that quality review boardssuch as CAPA Reviews Nonconformance Review Boards and Audit Reviewsoperate effectively to monitor QMS health and progress.
• Lead Management Review Meetings and monitor site-level Quality KPIs to drive data-based improvements.
• Generate review and approve Quality Assurance documentation required to support customer relationships product development regulatory filings and compliance verification activities.
• Drive projects and initiatives focused on cost savings QMS optimization and compliance enhancement.
• Manage and support Customer Corporate and Regulatory auditsincluding pre-audit planning backroom leadership hosting and post-audit corrective action follow-up.
• Perform additional duties as assigned to support business needs and strategic quality goals.

Education

• Bachelors Degree in a science related field or equivalent experience required and
• Masters Degree in a science related field preferred

Work Experience

• Minimum 8 years Quality experience required.
• Minimum 3 years of supervisory/management expeirnece required.
• Must possess knowledge of regulatory and governmental guidelines and requirements (21 CFR Part 820 ISO 13485 EU-MDR cGMP GLP).
• Experience in regulated industry such as pharmaceutical and medical device preferred.
• Experience with SAP systems preferred.

Preferred Knowledge Skills and Abilities

• Organizational skills will enable planning prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
• Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals and/or Plastics Manufacturing.
• Demonstrated people skills specific to team building problem solving root cause analysis and conflict resolution.
• Excellent presentation writing verbal computer interpersonal and communication skills.
• Experience in regulated industry such as pharmaceutical and medical device.
• In depth knowledge of cGMP cGDP relevant ISO standards and medical device requirements.
• Familiarity with document management databases particularly Master Control.
• Ability to adapt to frequent changes unexpected events and still yield an effective outcome.
• Manages competing demands makes timely and sound decisions even under conditions of risk.
• Accepts feedback from others ability to engender enthusiasm motivate peers and subordinates and teambuilding.
• Effectively influences actions and opinions of others. Ability to perform effectively and efficiently in a fast-paced environment.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the companys safety policy at all times.
• Able to comply with the companys quality policy at all times.

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to communicate effectively with written and oral skills make quick decisions interpret data read and write speak in front of groups express and exchange ideas understand direction and adhere to procedures
• Organizational skills will enable planning prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Able to routinely use standard office equipment such as computers phones photocopiers filing cabinets and fax machines
• Read and interpret data information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task work under time constraints problem solve and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations analyze and solve problems #LI-NJ1 #LI-Onsite