Senior Quality Management Systems Manager

🕒 il y a 18 jours

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $152 800 - $175 000 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 1%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Teleflex

Site WebLinkedInTous les Emplois

10 000+ employés

🏥 Santé

🏭 Fabrication

⚕️ Assurance santé

💰 €275 000 Venture Round en 2010-01

Healthcare • Manufacturing • Healthcare Insurance

Teleflex est un fournisseur mondial de dispositifs médicaux innovants et de solutions, dédié à soutenir les professionnels de santé et à améliorer les soins aux patients. Avec un portefeuille diversifié incluant des produits pour l'anesthésie, la médecine d'urgence, la cardiologie interventionnelle et bien plus, Teleflex vise à améliorer la santé et la qualité de vie. L'entreprise met l'accent sur son engagement envers l'éducation et le support client dans le secteur de la santé.

Description

• Lead global QMS governance, harmonization, and continuous improvement across sites and functions. • Lead regulatory and standards surveillance, gap assessments, and implementation of new or revised requirements. • Provide governance of CAPA, change management, document control, training, Management Review, and quality metrics. • Govern and oversee the Supplier Quality Program, including qualification, monitoring, performance, SCARs, and supplier risk. • Lead the Internal Audit Program, including audit planning, auditor qualification, execution, reporting, and follow-up. • Lead implementation and optimization of electronic QMS and Document Control systems within the ERP/eQMS environment. • Provide Quality oversight for computer software assurance/validation of quality-impacting systems. • Drive QMS performance, inspection readiness, and continuous improvement using metrics, trends, and risk-based decision-making. • Serve as a senior QMS subject matter expert during FDA, Notified Body, MDSAP, certification, and customer audits. • Oversee quality processes supporting customer information requests and change notifications. • Lead, coach, and develop the QMS team and partner with site and functional leadership to drive Quality System effectiveness.

🎯 Exigences

• Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related technical discipline. • 10+ years of Quality experience in the medical device or regulated life sciences industry. • 5+ years leading QMS programs or major Quality System initiatives. • 5+ years of people-management experience. • Advanced knowledge of ISO 13485 and FDA medical device QMS requirements. • Experience with global regulatory requirements, regulatory/standards gap assessments, and QMS implementation. • Strong experience with core QMS processes and Supplier Quality Program governance in a manufacturing environment. • Experience with regulatory inspections, Notified Body audits, MDSAP, and/or certification audits. • Demonstrated ability to lead complex, cross-functional and multi-site initiatives. • Strong leadership, analytical, communication, technical writing, and problem-solving skills. • Global or multi-site medical device QMS experience. • Knowledge of EU MDR and medical device requirements in Canada, Australia, Brazil, Japan, Switzerland, and the UK. • Experience with eQMS/ERP Quality systems, software assurance/validation, and ISO 14971 risk management. • Lead Auditor, ASQ CMQ/OE, CQA, RAC, or equivalent certification preferred.

🏖️ Avantages

• Medical insurance • Prescription drug insurance • Dental insurance • Vision insurance • Flexible spending accounts • Participation in 401(k) savings plan • Paid time off (PTO) • Short-term disability • Long-term disability • Parental leave