Associate Director

Cielo Talent; Arizona; On-site; USD 120,000 - 180,000; Full time

Job summary

Cielo, Inc. is seeking a senior Quality Manager to design, implement, and oversee quality systems across the Peripheral Intervention supply chain.

You will ensure regulatory compliance with FDA, ISO 13485, and other global requirements while guiding supplier quality activities and audits. You will lead a team of auditors, manage CAPAs and change controls, monitor supplier performance, and drive continuous improvement across sites.

Qualifications

• Minimum of 9 years experience in federally regulated industry including QA, quality systems, compliance and/or regulatory affairs.
• Minimum 5 years supervisory experience.
• Strong knowledge of Quality Risk Management, FDA, ISO 13485, MDD/MDR, ISO14971, and Canadian medical device requirements.
• Experience conducting quality audits (internal and supplier).
• Demonstrated experience leading engineering/technical teams.

Responsibilities

• Lead design, proposal, and implementation of quality systems across the Peripheral Intervention supply chain.
• Oversee supplier quality activities, audits, SCARs, and continuous improvement.
• Review CAPAs, investigations, change controls, and regulatory reports.
• Travel up to 25% and lead department personnel to achieve quality and regulatory objectives.
• Foster a culture of quality and regulatory awareness across sites and functions.

Skills

Quality management

Regulatory knowledge

Leadership

Auditing

Process improvement

Education

Bachelor's degree in a science-based discipline

Job description

Supply Chain QualityDesign, propose, and implement quality systems that ensure the ongoing compliance and effectiveness of the Peripheral Intervention supply chainPartner with functions including Integrated Supply Chain (ISC) and Purchasing to ensure procedures and processes meet regulatory expectations and uphold product qualityOwn and manage the product release and restriction process governing product distribution to global marketsLiaise with external service providers to update and maintain ERP system master dataPropose improvements to ERP system use and functionality to enhance long-term complianceManage Quality Agreements and contracts with PI customers and B2B partnersInfluence across sites and globally to drive meaningful improvements to global and corporate-wide proceduresReview and approve investigations, Corrective/Preventive Actions (CAPAs), change controls, and process updates related to the product Supply ChainVendor ManagementServe as Quality Manager for all supplier-quality related activitiesIdentify and execute process improvements and compliance initiatives related to supplier qualityRepresent PI at kaizens and forums regarding global and corporate-wide proceduresMonitor and measure supplier product and process qualityManage supplier audits, Supplier Corrective Action Requests (SCARs), and continuous improvement projectsParticipate in supplier business reviews to provide feedback on performance and discuss opportunities for future business and quality growthActively participate in facility audits (FDA, ISO, Internal, Notified Body, and Health Authority)Provide guidance to new product development teams related to supplier capabilities, supplier technical expertise, and overall ability of supplier to meet business needsEvaluate and provide guidance on documentation associated with supplier qualification and performance, including supplier-driven changes, Quality Agreements, evaluations, audit assessments, and regulatory reportsDevelop and manage a team of qualified auditors to complete vendor auditsOther projects and duties, as assignedAbility to travel up to 25% of the timeTeam LeadershipLead department personnel to achieve business, quality, and regulatory objectivesSet clear performance expectations and hold team members accountable for results and complianceFoster a culture of quality, continuous improvement, and regulatory awarenessConduct regular performance reviews, feedback sessions, and development planningIdentify skill gaps and implement training or cross-training to support operational needsAddress performance, behavioral, and compliance issues in a timely and constructive mannerSupport workforce planning, including succession planning and resource allocationCreate an inclusive work environment that encourages employee engagement, retention, and professional development

Responsibilities

• Design, propose, and implement quality systems that ensure the ongoing compliance and effectiveness of the Peripheral Intervention supply chain
• Partner with functions including Integrated Supply Chain (ISC) and Purchasing to ensure procedures and processes meet regulatory expectations and uphold product quality
• Own and manage the product release and restriction process governing product distribution to global markets
• Liaise with external service providers to update and maintain ERP system master data
• Propose improvements to ERP system use and functionality to enhance long-term compliance
• Manage Quality Agreements and contracts with PI customers and B2B partners
• Influence across sites and globally to drive meaningful improvements to global and corporate-wide procedures
• Review and approve investigations, Corrective/Preventive Actions (CAPAs), change controls, and process updates related to the product Supply Chain
• Serve as Quality Manager for all supplier-quality related activities
• Identify and execute process improvements and compliance initiatives related to supplier quality
• Represent PI at kaizens and forums regarding global and corporate-wide procedures
• Monitor and measure supplier product and process quality
• Manage supplier audits, Supplier Corrective Action Requests (SCARs), and continuous improvement projects
• Participate in supplier business reviews to provide feedback on performance and discuss opportunities for future business and quality growth
• Actively participate in facility audits (FDA, ISO, Internal, Notified Body, and Health Authority)
• Provide guidance to new product development teams related to supplier capabilities, supplier technical expertise, and overall ability of supplier to meet business needs
• Evaluate and provide guidance on documentation associated with supplier qualification and performance, including supplier-driven changes, Quality Agreements, evaluations, audit assessments, and regulatory reports
• Develop and manage a team of qualified auditors to complete vendor audits
• Other projects and duties, as assigned
• Ability to travel up to 25% of the time
• Lead department personnel to achieve business, quality, and regulatory objectives
• Set clear performance expectations and hold team members accountable for results and compliance
• Foster a culture of quality, continuous improvement, and regulatory awareness
• Conduct regular performance reviews, feedback sessions, and development planning
• Identify skill gaps and implement training or cross-training to support operational needs
• Address performance, behavioral, and compliance issues in a timely and constructive manner
• Support workforce planning, including succession planning and resource allocation
• Create an inclusive work environment that encourages employee engagement, retention, and professional development

Qualifications

• Education and Experience:Minimum of 9 years experience in federally regulated industry to include QA, Quality Systems, Compliance, and/or Regulatory Affairs.
• Minimum 5 years supervisory experience.
• Strong working knowledge of Quality Risk Management, FDA, ISO 13485, MDD/MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.
• Experience conducting quality audits (internal and supplier).
• Demonstrated experience leading engineering/technical teams

Required Skills

• Knowledge and Skills:Required Qualifications:Minimum of a four-year degree in an science-based discipline
• Experience in a manufacturing environment, preferably in a regulated industry (medical, automotive, aerospace, pharmaceutical, or similar)
• Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Effectiveness Verification
• Strong organizational skills
• Strong oral and written communication skills.
• Strong interpersonal skills

Preferred Skills

• Preferred Qualifications:Working knowledge of statistical quality tools and statistical process control (SPC)
• Knowledge of FMEA, Control Plans, Measurement System Analysis (MSA), First Articles, Validation - IQ/OQ/PQ)
• Industry Certification (e.g. ASQ CQE, CRE, CQA, CQM)
• Ability to analyze manufacturing and quality systems and provide recommendations for improvement