Quality Manager - Medical Device Manufacturing
About The Position
We’re a mid-sized medical device and contract manufacturer, which means you get the best of both worlds: meaningful work in a regulated environment without the layers of bureaucracy you’ll find at larger organizations. Here, your ideas don’t get lost in an approval chain. Team members are encouraged to provide feedback, share suggestions, and directly see the impact of their work on processes, products, and outcomes. What you contribute matters, and you can see it come to life. Because we’re growing and continuously improving, this role offers an opportunity to take meaningful ownership of the Quality function and help shape how Quality Systems and Quality Operations work together across the organization. We are looking for someone who enjoys being close to the work. This is not a purely strategic or administrative Quality position. The successful candidate will be comfortable working directly with Quality personnel, manufacturing, engineering and company leadership to solve problems, improve systems and ensure effective execution. Position Summary: The Quality Manager provides leadership and functional ownership of Quality within a medical-device manufacturing environment. This role is responsible for ensuring effective execution of the Quality Management System, operational Quality requirements, regulatory compliance and continuous improvement activities across the organization. The Quality Manager will oversee Quality Systems and Quality Operations personnel while remaining directly involved in key Quality activities including CAPA, nonconformance management, complaint handling, audit readiness, supplier quality, manufacturing-quality issues and Quality data analysis. The position exercises independent judgment in interpreting Quality data, assessing risk, determining appropriate Quality actions and ensuring issues are driven through effective resolution. Experience applying ISO 13485 and FDA medical-device Quality requirements within a manufacturing environment is particularly important to this role.
Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences or a related technical field, or an equivalent combination of education and progressive Quality experience.
- 5+ years of progressive Quality experience within medical-device manufacturing or a closely related FDA-regulated manufacturing environment.
- Demonstrated working knowledge of ISO 13485 and FDA medical-device Quality System requirements.
- Hands-on experience with manufacturing Quality, including nonconformance investigation, CAPA, root-cause analysis and corrective action.
- Experience participating in or representing an organization during external Quality audits or regulatory inspections.
- Previous experience managing direct reports or formally leading a Quality team or Quality function.
- Experience working cross-functionally with Manufacturing, Engineering and Operations to resolve Quality issues.
- Demonstrated ability to analyze Quality data, identify trends and convert findings into appropriate actions.
- Working proficiency with Microsoft Excel and other tools used to organize, analyze and communicate Quality data.
- Strong written and verbal communication skills with the ability to influence across functions and levels of the organization.
Nice To Haves
- Experience directly representing a medical-device manufacturer during ISO 13485, FDA, customer or other external audits.
- Experience managing both Quality Systems and operational/manufacturing Quality activities.
- Experience with supplier Quality, process validation, inspection systems and manufacturing-process improvement.
- Experience in a small to mid-sized medical-device manufacturing environment where Quality leaders operate across multiple Quality disciplines.
Responsibilities
- Provide leadership and functional ownership of the Quality organization, including Quality Systems and Quality Operations personnel, ensuring accountability for departmental performance, priorities, and results.
- Own the effectiveness and continuous improvement of the Quality Management System (QMS), ensuring compliance with ISO 13485, applicable FDA requirements, and other relevant regulatory and customer requirements.
- Maintain organizational readiness for internal, customer, registrar, and regulatory audits.
- Represent the company during audits and lead audit response, corrective action, and closure activities, ensuring findings are addressed effectively and within established timelines.
- Own and oversee CAPA, complaint, nonconformance, and quality investigation processes, ensuring appropriate prioritization, root cause analysis, corrective action development, effectiveness verification, and timely closure.
- Own the Quality function's response to production quality issues, partnering with Manufacturing and Engineering to ensure appropriate investigation, risk assessment, root cause identification, and implementation of sustainable corrective actions.
- Own the nonconforming material process and exercise delegated authority over product disposition decisions, as applicable, ensuring decisions are supported by documented risk assessments, established procedures, regulatory requirements, and product quality considerations.
- Analyze quality data, inspection results, defects, complaints, nonconformances, and other quality indicators to identify adverse trends, systemic issues, and opportunities for improvement.
- Establish priorities and drive appropriate corrective and preventive actions based on identified risks.
- Establish and maintain quality performance metrics and reporting to evaluate the effectiveness of the QMS and Quality organization, support data-driven decision-making, and hold the department accountable for addressing performance gaps and improvement opportunities.
- Own supplier quality oversight, including performance monitoring, escalation of significant quality risks, supplier corrective action requirements, and verification of effective resolution.
- Provide Quality oversight and establish appropriate quality controls for manufacturing process changes, validations, new product introductions, and other changes that may affect product quality, process performance, or regulatory compliance.
- Ensure operational quality findings and trends drive appropriate improvements to QMS procedures, training, risk controls, CAPA, and other quality processes in collaboration with Quality Systems personnel and relevant stakeholders.
- Establish departmental priorities, performance expectations, and accountability for Quality personnel.
- Lead coaching, performance management, and professional development to strengthen team capability and ensure effective execution of quality responsibilities.
- Develop the capabilities and organizational effectiveness of the Quality function as the company grows by identifying staffing and competency needs, addressing capability gaps, and participating in recruitment, workforce planning, and organizational development.
Benefits
- Health, dental, vision, basic life, and AD&D insurance
- 401(k) retirement plan with employer match
- Paid time off (Vacation and Protected paid time) and 6 company designated holidays
- Tuition Assistance Program
- Employee Brace Program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
