QMS Manager Job at ICEYE (Espoo)

Assistant Manager - QMS

Responsible for developing, implementing, maintaining, and continually improving...

Location

India , Chennai; Vengal, Tiruvallur

Salary:

Not provided

Nordex Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical / Industrial / Production / Quality Engineering
9-14 years of experience in Quality Function, with minimum 8 years in QMS roles
Strong knowledge of ISO 9001:2015 and other management system standards
Experience in internal audits, certification audits, document control, NCR/CAPA management
Skilled in quality tools (RCA, FMEA, LPA, MSA) and proficient in MS Office / QMS software
ISO 9001 Lead Auditor certification preferred
Strong communication, stakeholder alignment, and training capabilities
Structured, proactive and hands-on approach
able to handle multiple QMS activities simultaneously

Job Responsibility

Planning and implementing the Quality Management System as per ISO 9001 standards and Nordex Management system
Develop, maintain, and continuously improve the Quality Management System
Conduct internal audits and ensure readiness for external certification audits
Identify improvement opportunities in processes using root cause analysis, Lean tools, or Six Sigma methodologies
Coordinate External certification Bodies, verify closure of nonconformities with Certification Bodies and Ensure corrective actions are undertaken to address nonconformities found
Undertake regular internal and process assessment of the QMS
Review, implement and update company records e.g. training matrices, performance reviews, risk assessments
Conduct QMS-related training for employees (audit preparedness, document control, SOP awareness)
Conducting internal management reviews, Ensure KPIs are met by working to the plan, including management of, and reporting
Conduct risk assessments of processes and tasks in the department

Manager, Quality Systems (QMS)

As the Manager, Quality Systems, you will support the design, implementation, an...

Location

Canada , Vancouver

Salary:

94880.00 - 118600.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections

Fulltime

Associate Technician Trainee, Animal Care

Driven by integrity and united by the people-and-pet bond, we find strong purpos...

Location

United States , St. Joseph

Salary:

Not provided

Nestlé Purina

Expiration Date

Until further notice

Requirements

High School Diploma (or GED)
2+ years of professional animal handling/husbandry and/or regular care of animals

Job Responsibility

Organize and perform necessary work related to the care, palatability, or nutritional testing of the pets under general supervision
Knowledge of and compliance with the Animal Welfare Act and the Nestlé Purina R&D Petcare Manual
Adherence to Nestlé Quality Management Systems (QMS) and Good Laboratory Practices (GLP)
Accurately and reliably record data as outlined by the requesting project scientists
Collect and process samples for standard and non-standard nutrition tests
Obtain animal body weights and Body Condition Scoring (BCS)
Provide care including daily feedings of the pets and basic grooming
Report to the veterinary staff sick or unusual behavior observed in the pets

Fulltime

Senior Supplier Quality Engineer

As a global medtech company, we are driven by our Vision of changing the traject...

Location

United States , Clear Lake

Salary:

110000.00 - 120000.00 USD / Year

LivaNova

Expiration Date

Until further notice

Requirements

A Bachelor's Degree in Engineering is required
8+ Years of Quality or Manufacturing Engineering
Experience working in a regulated environment industry such as a FDA medical device manufacturer preferred
Understanding of basic quality engineering principles including, but not limited to: quality leadership, implementation, acceptance sampling, statistical process control, lean business systems and other continuous improvement techniques, and risk management
Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders
Good team player: open and honest when communicating among peers and management
Resolves most issues with peers, but understands what issues are important to escalate to management
Project management skills including the ability to drive cross-functional internal and external teams to completion of projects within planned timeframes
Strong interpersonal skills
Sustained record of performance during tenure in previous position as shown through consistency with which metrics in their areas of responsibility meet performance objectives as established in Management Review and a track record of implementing improvements

Job Responsibility

Leads the supplier selection, evaluation and approval process by assessing manufacturing/ technology capabilities, supplier risk levels, Quality Management System compliance, etc.
Serves as a core team member on component development teams by providing technical leadership and direction
Responsible for supplier process qualification, verification and validation activities
Reviews supplier process changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts and timely management of these changes with to ensure continued supply of parts
Acts as business process owner for all supplier related nonconformance report (NCR) management system, including material review board (MRB) activities, monitoring the timeliness and effectiveness of the system and activities
Carries out supplier Quality Management System (QMS) and process audits
Collaborates with suppliers on process manufacturing process improvement, process validation (TMV, IQ, OQ and PQ) and value enhancement opportunities
Ensures ongoing compliance per ISO 13485 and MDSAP requirements
Collaborates with Purchasing and procurement functions to support business strategy initiatives including cost saving efforts, alternate sourcing, outsourced processes etc.
Provides quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for receiving inspection activities

What we offer

Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules
discretionary annual bonus

Fulltime

Process Engineering Specialist

This is a multi-faceted position providing process engineering support to the fa...

Location

United States , Sudbury

Salary:

100000.00 - 115000.00 USD / Year

Nestlé Purina

Expiration Date

Until further notice

Requirements

BS Degree in Chemical, Mechanical Engineering or a related field
3+ years of experience in process engineering & projects field
Experience in a food, dairy, pharmaceutical, etc manufacturing plant environment (preferably in infant formula and/or medical nutritional, dairy processing, spray drying process, or food / fluid products). Aseptic experience is a plus Preferred.
Ability to work flexible hours
Above average communication skills (written and oral)
Above average project management skills preferably in handling large scale projects (< $750,000)
Problem-solving skills
Ability to prioritize
Knowledge of Microsoft Word, Project and Excel required
SAP, AutoCAD experience is preferred

Job Responsibility

Provide process engineering support to the factory in capital project execution and process line support.
Responsible for project management, production line trouble shooting, administering budgeting, design, installation, qualification, and commissioning of new/modified process systems.
Assist Production and Quality Departments to resolve non-maintenance related production and quality issues.
Conduct training, maintain and update documentation relating to job.
Assist in training and mentoring of new engineering staff.
Follow up investigation using root cause analysis tools such as GSTD and/or DMAIC on process related issues
Provide resolution of process line quality deviations thru formal requests such as ODIR, process deviations, and NCR's
Investigation feasibility and scope analysis to determine potential operational improvements
Independently develop and design process systems for manufacturing of food products including liquid and powder
Conduct budget estimation, planning, and execution of projects.

What we offer

performance-based incentives
401k with company match
healthcare coverage
broad range of other benefits
physical, financial, and emotional wellbeing support
professional growth opportunities
dynamic career paths
robust development
opportunities to learn from talented colleagues around the globe

Fulltime

Electrical Quality Control Inspector

The Quality Control Inspector is responsible for following the M.C. Dean Quality...

Location

United States , Caroline County

Salary:

Not provided

M.C. Dean, Inc

Expiration Date

Until further notice

Requirements

Associates Degree in Technical Discipline (may be substituted for quality related experience)
At least 4 years hands-on experience in the electrical industry
To possess or have the ability to obtain a state issued Journeyman License within 6 months of hire
Experience with reading and interpreting contractual requirements, drawings, BIM models, specifications, current NEC codes, NETA and other applicable standards
Experience with receiving, production, shipping and quality processes
Excellent communication skills (written, and verbal)
Strong attention to details, highly organized and computer literate
Ability to work well in a fast-paced manufacturing environment

Job Responsibility

Conduct inspections to ensure compliance and conformance with project or contract specifications
Conduct inspections in accordance with Quality Control Plan
Conduct inspections to ensure adherence to applicable legal requirements
Confer with Quality Assurance, Manager as appropriate
Read blueprints and specifications
Monitor operations to ensure that they meet specifications
Recommend adjustments to the assembly or installation process
Inspect, identify, and submit material, components, or products for testing and measurement
Operate electronic inspection equipment and software
Document approval or rejection of inspected material, components, or products

What we offer

A competitive salary
Medical, dental, vision, life, and disability insurance
Paid-time off
Tuition reimbursement
401k Retirement Plan
Military Reserve pay offset
Paid maternity leave

Fulltime

Quality Systems PMO Program Manager

Are you a strategic PMO leader looking to spearhead large-scale compliance and o...

Location

United Kingdom , Basingstoke

Salary:

27.00 GBP / Hour

Randstad

Expiration Date

July 02, 2026

Requirements

7+ years of experience managing complex global Quality Systems, PMO, or enterprise transformation programs
Proven background within highly regulated industries such as Life Sciences, Medical Devices, Diagnostics, Biotechnology, or Pharmaceuticals
Strong experience with enterprise QMS harmonisation, quality systems integration, and operational transformation
Demonstrated experience integrating Supplier Quality, Commercial QMS, Manufacturing Quality, or Distribution Quality processes
Experience supporting regulatory inspections, remediation programs, and compliance transformation initiatives
Background using Lean, Six Sigma, PPI, or other continuous improvement methodologies is preferred
Strong knowledge of Quality Management Systems, enterprise quality governance models, and digital quality software platforms
Deep technical understanding of core quality processes (CAPA, change control, audits, supplier quality, training, and document management)
Strong understanding of global quality regulations and standards including FDA, ISO 13485, GMP, and GDP
High-level stakeholder management and executive communication capabilities, with experience developing governance frameworks, dashboards, and KPIs

Job Responsibility

Program Leadership & Governance: Define program deliverable, timelines, governance structures, and success metrics for global QMS harmonisation initiatives. Orchestrate PMO reviews, steering committee meetings, and quality councils
QMS Integration & Harmonisation: Drive the integration of Distribution Centres and supplier quality processes into enterprise QMS frameworks. Support the standardisation of core quality processes including CAPA, Change Control, Document Control, Training, Audit Management, and Complaint Handling
Risk & Change Management: Identify, monitor, and mitigate program risks such as compliance gaps, operational disruptions, and integration challenges. Build alignment across business units to drive the adoption of harmonised standards and operating models
PMO Metrics & Reporting: Coordinate enterprise-wide inputs to build standardised reporting, KPI visibility, governance dashboards, and actionable quality insights for senior leadership
Inspection Readiness & Continuous Improvement: Lead cross-functional remediation and quality transformation initiatives to support regulatory inspections and internal audits. Use Lean, Six Sigma, and operational excellence methodologies to drive process optimisation and simplification

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Project Manager - MES (Medical Devices / Life Sciences)

We are currently seeking a Project Manager - MES (Medical Devices / Life Science...

Location

Puerto Rico , San Juan

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

10+ years of strong proficiency in: C#, ASP.NET, .NET Core, SQL Server, WPF or Blazor (for HMI/Dashboard development)
5+ years of experience with MES architecture and shop floor system integration (PLCs, SCADA)
Proven experience managing MES implementations in: Life Sciences, Medical Devices (Class II/III preferred)
PMP (Project Management Professional) OR Certified Scrum Master (CSM)
Strong understanding of Quality Management Systems (QMS)
Familiarity with: FDA 21 CFR Part 11, GAMP standards, ISO 13485, FDA Design Controls
Hands-on experience with Computer System Validation (CSV)
Strong documentation and audit readiness experience
Strong leadership and stakeholder management
Excellent communication and reporting skills

Job Responsibility

Define project scope, objectives, and deliverables in collaboration with senior management and key stakeholders
Develop comprehensive project plans including timelines, milestones, and resource allocation
Drive end-to-end execution of MES implementation projects, ensuring alignment with organizational goals
Forecast project requirements and manage budgets effectively
Track project expenses and identify/mitigate variances proactively
Optimize resource utilization across teams and project phases
Lead cross-functional teams including software engineers, automation specialists, and QA teams
Delegate tasks effectively, ensuring accountability and high performance
Drive delivery using Agile or hybrid SDLC methodologies
Identify and mitigate project risks, issues, and bottlenecks

Fulltime

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QMS Manager

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