Manager Quality Assurance
Chi siamo
ENOVIS™
Who We Are
ABOUT ENOVIS™
Di cosa ti occuperai | What You'll Do
Job Purpose:
The Quality Assurance Manager leads the site's quality assurance strategy, ensuring regulatory compliance, operational excellence, and product quality across all stages of the manufacturing process. By driving quality systems, supplier quality, validation activities, and continuous improvement initiatives, this role plays a critical part in delivering safe, reliable, and compliant medical device solutions to customers worldwide.
Key Contributions
- Lead, develop, implement, and maintain quality systems, processes, and activities across the Quality Engineering, Supplier Quality, and Validation teams.
- Establish and implement quality standards, methods, and procedures for the inspection, testing, and evaluation of products to ensure quality, accuracy, reliability, and compliance with specifications.
- Ensure compliance with applicable company standards, industry regulations, and relevant government requirements.
- Participate in the review and assessment of engineering designs, providing quality expertise and recommendations.
- Support Product Support and other cross-functional teams in collecting, analysing, and interpreting quality-related data.
- Monitor and evaluate product quality and performance, ensuring accurate reporting of key quality metrics and presenting relevant findings during management reviews.
- Maintain strong knowledge of FDA medical device regulations, ISO 13485, and MDSAP requirements, and represent the business during relevant regulatory and quality audits.
- Oversee root cause analysis, Corrective and Preventive Actions (CAPA), and nonconforming product management, ensuring effective resolution and prevention of quality issues.
- Partner with Manufacturing to ensure compliance with quality requirements and the effective implementation of risk controls throughout production processes.
- Maintain overall responsibility for component and production quality, ensuring products meet established quality standards and regulatory requirements.
- Provide leadership and direction to the team, with managerial authority and responsibility for recruitment, performance management, disciplinary actions, and employee development.
- Manage the department's budget, ensuring effective resource allocation and financial oversight.
Skills and Qualifications
- Bachelor's degree in Engineering, Quality Management, or a related field.
- Minimum of 5 years of experience in Quality Assurance.
- Minimum of 3 years of management experience, preferably leading Quality or Engineering teams.
- Solid understanding and practical experience in root cause analysis, CAPA, and nonconforming product management.
- Experience participating in and representing an organisation during regulatory and quality audits.
- Lean or Six Sigma experience preferred.
Dichiarazione di pari possibilità
Enovis si impegna a garantire pari opportunità di lavoro a tutti. Le decisioni relative all'assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego.
Equal Employment Opportunity
ENOVIS™
Who We Are
ABOUT ENOVIS™
Di cosa ti occuperai | What You'll Do
Job Purpose:
The Quality Assurance Manager leads the site's quality assurance strategy, ensuring regulatory compliance, operational excellence, and product quality across all stages of the manufacturing process. By driving quality systems, supplier quality, validation activities, and continuous improvement initiatives, this role plays a critical part in delivering safe, reliable, and compliant medical device solutions to customers worldwide.
Key Contributions
- Lead, develop, implement, and maintain quality systems, processes, and activities across the Quality Engineering, Supplier Quality, and Validation teams.
- Establish and implement quality standards, methods, and procedures for the inspection, testing, and evaluation of products to ensure quality, accuracy, reliability, and compliance with specifications.
- Ensure compliance with applicable company standards, industry regulations, and relevant government requirements.
- Participate in the review and assessment of engineering designs, providing quality expertise and recommendations.
- Support Product Support and other cross-functional teams in collecting, analysing, and interpreting quality-related data.
- Monitor and evaluate product quality and performance, ensuring accurate reporting of key quality metrics and presenting relevant findings during management reviews.
- Maintain strong knowledge of FDA medical device regulations, ISO 13485, and MDSAP requirements, and represent the business during relevant regulatory and quality audits.
- Oversee root cause analysis, Corrective and Preventive Actions (CAPA), and nonconforming product management, ensuring effective resolution and prevention of quality issues.
- Partner with Manufacturing to ensure compliance with quality requirements and the effective implementation of risk controls throughout production processes.
- Maintain overall responsibility for component and production quality, ensuring products meet established quality standards and regulatory requirements.
- Provide leadership and direction to the team, with managerial authority and responsibility for recruitment, performance management, disciplinary actions, and employee development.
- Manage the department's budget, ensuring effective resource allocation and financial oversight.
Skills and Qualifications
- Bachelor's degree in Engineering, Quality Management, or a related field.
- Minimum of 5 years of experience in Quality Assurance.
- Minimum of 3 years of management experience, preferably leading Quality or Engineering teams.
- Solid understanding and practical experience in root cause analysis, CAPA, and nonconforming product management.
- Experience participating in and representing an organisation during regulatory and quality audits.
- Lean or Six Sigma experience preferred.
Dichiarazione di pari possibilità
Enovis si impegna a garantire pari opportunità di lavoro a tutti. Le decisioni relative all'assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego.
Equal Employment Opportunity