20 beste Stellen als of compliance in prilly vd – aktuell auf Personalsuche

Manager Quality Operations
ONWARD Medical —Lausanne, VD
- Englisch
- Master
- Produktion
Senior Veeva Systems Specialist Pharma
Axepta —Lausanne, VD
- Management-Erfahrung
- Salesforce
- Englisch
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Evooq —Lausanne, VD
- 100%
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1 Tag
Technical Project Manager (m/f/d) – Low-Voltage Projects (80–100%)
Schneider Electric —Crissier, VD
- 100%
- Englisch
1 Std.
Consultant - Corporate Tax - Lausanne
KPMG —Lausanne, VD
- 100%
- Homeoffice
- Englisch
- Master
- Analysefähigkeit
- Homeoffice-Möglichkeit
- Eltern-/Erziehungsurlaub
P2613 - CSV Lead
Debiopharm —Lausanne, VD
- 100%
- Englisch
- Master
- Analysefähigkeit
Direkt bewerben
Senior System Engineer
Viasat —Lausanne, VD
- Bachelor
- Führungserfahrung
- Kommunikationsfähigkeit
Program Manager, Inmarsat-8, Space Infrastructure
Viasat —Lausanne, VD
- Management-Erfahrung
- Analysefähigkeit
- Produktion
P2611 - Senior Legal Counsel - Commercial & Privacy
Debiopharm —Lausanne, VD
- 100%
- Englisch
- Master
Direkt bewerben
Technician - Mouse Surgery & Neuroscience
emploi.epfl.ch —Lausanne, VD
- Englisch
- Forschungserfahrung
- Master
Environmental Consulting Associate (Geologist, Hydrogeologist or Environmental Engineer)
ERM Group —Lausanne, VD
- 100%
- Englisch
- Projektmanagement
- Budgetierung
- Erfolgsbeteiligung
- Pensionskasse
Cleaning Validation Expert (m/f/d)
Merck KGaA —Aubonne, VD
- 100%
- Schreibfähigkeiten
- Englisch
- Master
- Aufstiegsmöglichkeiten
UAV Battery Engineer
Harmattan AI —Lausanne, VD
- 100%
- Master
- Bachelor
- Produktion
9 Tage
Senior System Engineer
Viasat, Inc. —Lausanne, VD
- 100%
- Homeoffice
- Bachelor
- Führungserfahrung
- Kommunikationsfähigkeit
Quality Control Manager
ADM —Rolle, VD
- 100%
- Laborerfahrung
- Englisch
- Bachelor
11 Tage
International Product Manager
Tandem Diabetes Care —Lausanne, VD
- 100%
- Management-Erfahrung
- Englisch
- Master
Direkt bewerben
2 Tage
Test Engineer – Wireless & Mobile Networks (Switzerland)
Marquistech —Lausanne, VD
- 100%
- Englisch
- Analysefähigkeit
- Erfahrung mit Netzwerken
Product Marketing Intern
Bio-Techne —Tolochenaz, VD
- 100%
- CRM-Software
- Englisch
Account Executive DACH
DuoKey —Prilly, VD
- Homeoffice
- Englisch
- Bezahlte Ferien
Direkt bewerben
Quality Control Engineer
GXP Consulting Switzerland —Epalinges, VD
- Wartung
- Englisch
- Master

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Manager Quality Operations

ONWARD Medical -
Lausanne, VD

Jetzt bewerben

Details zur Stelle

Festanstellung

Qualifikationen

Englisch
Master
Risikomanagement
Produktion
Führungserfahrung
Kommunikationsfähigkeit
ISO 13485

Vollständige Stellenbeschreibung

The Manager Quality Operations is responsible for leading and managing all aspects of Quality Operations, including Quality Control (QC) and Product Release, Supplier Quality Engineering (SQE), and oversight of Contract Manufacturing Organizations (CMOs) and key suppliers, including distributors. This role ensures that products are manufactured and released in full compliance with applicable quality and regulatory standards. The Manager Quality Operations leads a team of Quality Engineers and Quality Technicians, and holds the authority for product release.

Responsibilities

Quality Operations:

Oversee and manage day-to-day quality activities across internal operations and external manufacturing partners (CMOs).
Ensure that all manufacturing and assembly activities, both internal and outsourced, are conducted in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
Review and approve Device History Records (DHRs), lot release documentation, and Certificates of Analysis/Conformance from suppliers and CMOs.
Support quality oversight of technology transfers, process validations, and change control involving CMOs and suppliers.
Collaborate cross-functionally with Procurement, Supply Chain, R&D, and Manufacturing to ensure production quality and regulatory compliance.
Manage quality operations processes including deviations, nonconformances, and CAPAs related to production and incoming materials.

Quality Control (QC):

Supervise inspection and testing of incoming materials, in-process components, and final products.
Ensure testing protocols are validated and consistently followed.
Analyze trends from inspection data and initiate quality improvements as needed.
Act as primary backup for Quality Control activities

Supplier Quality Engineering (SQE):

Qualify, audit, and monitor suppliers, distributors and CMOs to ensure compliance with Onward Medical’s quality standards.
Establish and maintain Quality Agreements, define inspection criteria, and evaluate supplier performance metrics.
Manage and assess Supplier Change Requests to ensure appropriate risk evaluation, documentation, and approval before implementation.
Lead investigations into supplier-related nonconformances, ensuring effective root cause analysis and implementation of corrective actions.
In collaboration with Purchasing department, actively lead supplier development initiatives by establishing structured performance management frameworks, fostering strategic partnerships, and driving continuous improvement

Product Release Authority:

Act as the final quality approver for product release, ensuring compliance with product specifications, quality records, and applicable regulations.
Sign off on batch release documentation and contribute to regulatory submissions as needed.
Act as primary backup for Product Release activities.
Serve as backup for the final quality approval of product releases conducted at other Onward manufacturing sites.

Experience, Qualifications & Skills

Master’s degree in Engineering, Life Sciences, or related discipline.
Minimum 8 years of experience in Quality roles within the electromechanical medical device industry, with at least 3 years in a leadership capacity.
Proven experience managing CMOs and suppliers in a regulated environment.
Solid understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory frameworks.
Hands-on experience with Supplier Change Request (SCR) processes, CAPA, risk management, and process validation.
Proficiency with quality tools (e.g., 8D, FMEA, SPC).
Excellent communication, collaboration, and leadership skills.
Fluent in English; other languages are a plus.

Supervision

Lead, mentor, and support a team of Quality Engineers and Quality Technicians.
Allocate tasks and resources to meet department goals and production deadlines.
Foster a proactive, quality-focused culture throughout the organization.

Jetzt bewerben

Erweiterte Suche

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Manager Quality Operations

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Consultant - Corporate Tax - Lausanne

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Program Manager, Inmarsat-8, Space Infrastructure

P2611 - Senior Legal Counsel - Commercial & Privacy

Technician - Mouse Surgery & Neuroscience

Environmental Consulting Associate (Geologist, Hydrogeologist or Environmental Engineer)

Cleaning Validation Expert (m/f/d)

UAV Battery Engineer

Senior System Engineer

Quality Control Manager

International Product Manager

Test Engineer – Wireless & Mobile Networks (Switzerland)

Product Marketing Intern

Account Executive DACH

Quality Control Engineer

Ich möchte aktuelle Job-E-Mails für Stellen als of compliance in prilly vd erhalten

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