Director Quality Operations

Inogen; Montpellier; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

A leading medical device company in Montpellier, France is seeking a Director of Quality Operations to ensure product quality and compliance. The ideal candidate will have significant experience in quality roles within medical device companies, possess excellent communication skills, and demonstrate proficiency in EU and US regulatory standards. This role offers the chance to lead a dedicated quality team and manage compliance initiatives.

Prestations

Consultant or freelance contract flexibility

Qualifications

• At least ten years in a quality related role with medical device companies.
• At least five years of people management experience in a quality manufacturing role.
• Demonstrated expertise in quality manufacturing within US and EU medical device regulations.

Responsabilités

• Ensure product quality and compliance requirements are achieved.
• Lead and manage Quality Operations personnel.
• Support design related projects as required.

Connaissances

Quality manufacturing experience

People management

Communication skills

Collaborative skills

Knowledge of EU MDR/CE and US FDA regulations

Bilingual in French and English

Formation

Bachelor of Science degree

Description du poste

The Director Quality Operations is responsible for ensuring product quality, compliance, and business objectives associated with the Inogen facility located in Montpellier, France. The position is located in Montpellier, France. The position reports directly to SVP Quality & Regulatory.

Responsibilities

• Ensure product quality and compliance requirements are achieved
• Ensuring adequate and appropriate Quality manufacturing staffing in place to support business objectives
• Lead and manage Quality Operations personnel ensuring product quality and compliance objectives are achieved
• Lead and manage Quality Operations personal in activities such as incoming inspection, in process/finished device testing and release, NCMR, SCAR, CAPA, calibration, process/test method validation, design transfer, etc.
• Support design related projects as required
• Participate in internal and external audits
• Participate in supplier qualification and selection activities
• Collaborate with Supply Chain, Operations, etc. to address supplier related quality issues, supply chain issues, supplier improvements, etc.
• Participate and collaborate in cross functional teams in support of business objectives
• Support complaint investigations, HHE’s, and Field Actions upon request
• Support manufacturing and repair operations from a quality operations perspective to ensure order fulfillment and project initiatives
• Participate in AOP and remain within allocated budget

Educational Prerequisites and Skill Requirements

• Bachelor of Science degree
• At least ten years in a quality related role with medical device companies of >500m USD annual revenue and sales in EU and US
• At least five years in a quality manufacturing related role with medical device companies of >500m USD annual revenue and sales in EU and US
• At least five years of people management experience with medical device companies of >500m USD annual revenue and sales in EU and US
• Demonstrated knowledge and proficiency of EU MDR/CE and US FDA medical device regulations
• Demonstrated expertise in quality manufacturing within US and EU medical device regulations, such as quality engineering principles (e.g. statistics, risk management, sampling), incoming inspections, process and test method validation, finished device inspection, calibration, internal/external audits, etc.
• Proven track record of successfully achieving and maintaining compliance to EU MDR/CE and US FDA medical device regulations and achieving business objectives.
• Must have excellent communication, presentation and influencing skills.
• Must be highly collaborative and thrive in a team environment
• Must have written and verbal proficiency in French and English
• Must be able to travel ~25% domestic/international
• Consultant, freelance, fixed-term contract