Quality Manager

Sparrow Company•Glenview, IL

17d

About The Position

The Quality Manager is responsible for ensuring compliance with ISO 13485 and FDA 21 CFR 820, including maintaining FDA registration for Class 1 and Class 2 devices. The role establishes and maintains quality management systems, develops quality policies and procedures, oversees audits and quality metrics, and coordinates regulatory assessments. It also addresses customer complaints and nonconformances through root cause analysis and corrective and preventive actions. The Quality Manager monitors product quality, complaint trends, and nonconformance incidents; collaborates with product development and other teams to embed quality in design, development, and manufacturing; and develops risk management plans and activities throughout the product lifecycle. The role coordinates with R&D, manufacturing, regulatory affairs, and supply chain, maintains process validation documents, and conducts training to strengthen staff capabilities in quality and regulatory activities.

Requirements

Bachelor’s degree in chemistry, engineering, general science, or quality, or equivalent experience.
Five years of experience in a similar position.
Experience applying quality systems.
Effective communication and negotiation skills.
Experience implementing improvements and LEAN / Six Sigma methodologies in manufacturing processes.
Experience with problem-solving techniques.
Strong analytical skills to interpret complex data and make informed decisions.
High attention to detail.
Ability to identify issues, analyze root causes, and propose effective solutions.
Ability to collaborate with other departments, including operations and supply chain.
English language proficiency.
Excel required.

Nice To Haves

Chemistry, chemical engineering, or materials engineering degree preferred.
Familiarity with LEAN / Six Sigma tools.
Bilingual Spanish preferred.
Experience with ERP software such as NetSuite or Adage / Assistics preferred.
Experience with QPulse QMS software preferred.

Responsibilities

Establish and maintain quality management systems aligned with applicable FDA and ISO requirements and organizational objectives.
Develop and implement quality policies, procedures, and work instructions.
Supervise internal audits and management reviews to assess QMS effectiveness and identify improvement opportunities.
Monitor FDA regulations, ISO standards, and other relevant guidelines; develop strategies to ensure compliance.
Coordinate FDA inspections, ISO audits, and other regulatory assessments, and ensure findings are addressed promptly.
Monitor and analyze product quality metrics, complaint trends, and nonconformance incidents.
Implement corrective and preventive actions for nonconformances and complaints, including root cause analysis.
Collaborate with product development teams to integrate quality considerations into design, development, and manufacturing.
Develop and maintain risk management plans and strategies for product- and process-related hazards, failures, or adverse events.
Assist with and implement risk assessments, FMEA, and other risk management activities throughout the product lifecycle.
Identify, assess, and mitigate risks related to product quality, regulatory compliance, and business operations.
Collaborate with R&D, manufacturing, regulatory affairs, and supply chain to support compliance, accountability, continuous improvement, and alignment of quality and regulatory objectives with business goals.
Implement and maintain process validation documents.
Conduct training and development programs for staff involved in quality and regulatory activities.
Oversee internal quality KPIs and host customer, ISO registrar, and FDA external audits.
Develop and initiate standards and methods for inspection, testing, and evaluation.
Formulate and maintain quality objectives and coordinate them with procedures and other disciplines.
Participate in planning and designing quality procedures.
Maintain FDA registration for Class 1 and Class 2 devices.