Senior Quality System Specialist
Il y a 5 mois
**Senior Quality System Specialist (maternity leave)**:
- Work mode: Hybrid- Onsite Location(s): Voisins le Bretonneux, France**Additional Locations**: France-Voisins le Bretonneux; Ireland-Galway; Netherlands-Kerkrade; Spain-Madrid
**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.
At Boston Scientific, we’ll give you the opportunity to utilize and develop your skills and competencies by working in a team of diverse and high-performing employees, tackling some of the most important health industry challenges.
Remote Eligible: Hybrid
Onsite Location(s): Kerkrade, Netherlands or Galway, Ireland or Madrid, Spain
**About the Role**:
The Senior Quality Systems Specialist will provide Quality Systems support to the Europe, Middle East and Africa (EMEA) region. The Quality Systems team is responsible for full quality system oversight and specific functional responsibilities (Management Controls, Training, Audits, Supplier Management, Document and Records Control, and NCEP/CAPA) for Boston Scientific.
**Your responsibilities include**:
- Implement, maintain, and improve the EMEA Quality Management System.
- Responsible for working with QA management, department personnel and other areas on process reviews and implementation of requirements in compliance programs.
- Ensures Annual Global Quality Systems Objectives and Metrics are understood and achieved in line with BSC Best4 Quality Strategy and report metrics related at regional level
- Act as CAPA coordinator to monitor timely completion of NCEP and CAPA phases, provide support to NCEP owners, act as mentor to CAPA owners and actively participate in CAPA team meetings.
- Prepare material for and conduct regularly scheduled CAPA Review Board meetings.
- Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements.
- Plan and conduct supplier and 3PL assessments.
- Support site level internal/external audits acting as Subject Matter Expert (SME).
- Provide functional support as an SME as applicable to internal & external functions.
- Act as a coach/ mentor to aid development of junior staff members.
- Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, VIP, QMP, StAR, Lean, 5S).
- Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally.
- Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
- Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments of Boston Scientific
- Is viewed as a leader in the areas of QSR and ISO/MDR standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions using the Quality Systems Manager/ Site QA Director as the final arbitrator on critical quality decisions.
**What we are looking for**:
- 5+ Years relevant experience in the Medical Device, Pharma or Food environment
- Experience with nonconformance and CAPA investigation tools
- Green Belt certified (is a plus) with process management experience
- Nonconformance/CAPA and Quality Systems experience required
- Familiar with quality tools and problem-solving techniques
- Team player with strong work ethic and positive mentality
- Computer literate
- Good social and communication skills
- Strong analytical skills, "self-starter" and eager to improve
- English language proficiency
- Availability to travel when business functions require
**Requisition ID**:577031
**Job Segment**:QA, Quality Assurance, CAPA, Compliance, Law, Technology, Quality, Management, Legal
-
Senior Quality System Specialist
il y a 1 mois
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
il y a 3 semaines
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess and evaluate the Magellan implementation impact locally on the EMEA Satellite offices...
-
Senior Quality System Specialist
il y a 2 semaines
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices, working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess and evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
il y a 2 semaines
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
il y a 3 semaines
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
il y a 3 semaines
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices, working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess and evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
il y a 2 semaines
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
Il y a 2 mois
Voisins-le-Bretonneux, Île-de-France Boston Scientific Temps pleinAbout the Role:The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite offices in...
-
Senior Quality System Specialist
Il y a 3 mois
Voisins-le-Bretonneux, France Boston Scientific Temps pleinAbout the role: The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite...
-
Project Quality Assurance Specialist
il y a 4 semaines
Montigny-le-Bretonneux, Île-de-France MPH Consulting Services Temps pleinProject Quality Engineer Job DescriptionWe are seeking a highly skilled Project Quality Engineer to join our team at MPH Consulting Services.Key Responsibilities:Maintain and implement a robust Quality Management System (QMS) to ensure compliance with regulatory requirements.Develop and deploy quality assurance strategies across various projects, focusing on...
-
Project Quality Assurance Specialist
il y a 3 semaines
Montigny-le-Bretonneux, Île-de-France MPH Consulting Services Temps pleinJob Title: Project Quality EngineerWe are seeking a highly skilled Project Quality Engineer to join our team at MPH Consulting Services.Key Responsibilities:Maintain an effective Quality, Safety, and Environment Management System (QSE) for employees and subsidiaries.Deploy and manage quality assurance within various projects, ensuring compliance with...
-
Project Quality Assurance Specialist
il y a 3 semaines
Montigny-le-Bretonneux, Île-de-France MPH Consulting Services Temps pleinProject Quality EngineerWe are seeking a highly skilled Project Quality Engineer to join our team at MPH Consulting Services.Key Responsibilities:Maintain an effective Quality, Safety, and Environment Management System (QSE) for employees and subsidiaries.Deploy and manage quality assurance within various projects, ensuring compliance with customer...
-
Spécialiste en Systèmes de Communication
il y a 3 semaines
Voisins-le-Bretonneux, Île-de-France SPHEREA ARCALE Temps pleinDéveloppeur de Solutions InformatiquesVous rejoignez notre équipe de développement à SPHEREA ARCALE en tant que Spécialiste en Systèmes de Communication. Vous serez chargé de l'élaboration de solutions informatiques innovantes pour répondre aux besoins de nos clients dans le domaine de la défense.ResponsabilitésEffectuer des démonstrations et...
-
Quality Assurance Specialist
il y a 5 jours
Le Mans, Pays de la Loire, France Crédit Agricole Assurances Temps pleinKey Responsibilities:Develop and implement quality assurance processes to ensure high-quality software products.Collaborate with cross-functional teams to identify and prioritize quality assurance needs.Design and execute test plans to validate software functionality.Analyze and report defects to development teams.Requirements:Strong understanding of quality...
-
Quality Control Specialist
il y a 2 semaines
Le Cannet, Provence-Alpes-Côte d'Azur, France International Flavors & Fragrances Temps pleinJob DescriptionAt International Flavors & Fragrances, we are seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for performing laboratory tests on raw materials and products to ensure they meet our high standards of quality and safety.Key ResponsibilitiesPerform chemical, physical,...
-
Data Management Specialist
Il y a 2 mois
Voisins-le-Bretonneux, Île-de-France Danfoss Temps pleinJob SummaryWe are seeking a highly skilled Digital Data Assistant to join our team at Danfoss. As a Digital Data Assistant, you will be responsible for providing exceptional support to our clients by extracting and formatting data from our systems, creating high-quality digital assets, and ensuring the accuracy and integrity of our digital data.Key...
-
Quality Assurance Specialist
il y a 4 semaines
Nouvion-le-Comte, Hauts-de-France West Pharmaceutical Services Temps pleinJob Title: Quality Assurance SpecialistAt West Pharmaceutical Services, we are committed to improving patient lives through innovative solutions. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Manage customer complaints and lead customer communication in a timely...
-
Quality Assurance Specialist
il y a 2 semaines
Nouvion-le-Comte, Hauts-de-France West Pharmaceutical Services Temps pleinAt West Pharmaceutical Services, we're committed to improving patient lives through our dedication to quality and customer satisfaction. Our team is responsible for ensuring that our products meet the highest standards of quality, safety, and efficacy.As a Quality Assurance Specialist, you will be responsible for managing customer complaints, leading...
-
Senior Manager Customer Quality Manager
Il y a 5 mois
Le Pont-de-Claix, France BD Temps plein**Job Description Summary**: BD Medical - Pharmaceutical Systems is a global leader in supplying the pharmaceutical industry with innovative, high-quality, clinically proven, and customized pre-fillable parenteral drug delivery systems. Our offering includes an extensive portfolio of pre-fillable syringes, self-injection systems, safety, and shielding...
-
Quality Assurance Specialist
il y a 2 semaines
Nouvion-le-Comte, Hauts-de-France West Pharmaceutical Services Temps pleinAt West Pharmaceutical Services, we're committed to improving patient lives through our dedication to quality and excellence. Our team is passionate about delivering life-saving and life-enhancing injectable medicines to millions of patients daily. We're seeking a skilled Quality Assurance Specialist to join our team and contribute to our mission.As a...
