QM Specialist (CAPA and Change Management) Job at Aignostics (Berlin)

Quality Manager Specialist (CAPA and Change Management)

As a QM Specialist (CAPA and Change Management) you'll own the development and e...

Location

Germany , Berlin

Salary:

Not provided

Aignostics

Expiration Date

Until further notice

Requirements

Proven expertise in quality management systems, CAPA methodologies, and change control processes
Strong proficiency with root cause analysis tools (5 Whys, Fishbone diagrams, Fault Tree Analysis)
Solid understanding of ISO 13485, ISO 14971, IEC 62304, IVDR, and 21 CFR Part 820
Experience planning, conducting, and supporting internal and external audits
Excellent written and verbal communication skills in English
Ability to influence and collaborate effectively with diverse stakeholders at all levels

Job Responsibility

Build Robust Quality Systems: Establish and maintain CAPA management systems in full compliance with ISO 13485
Design and oversee change management processes aligned with ISO 13485 and IEC 62304
Maintain comprehensive QM documentation including SOPs, work instructions, and quality records
Translate regulatory requirements (IVDR, ISO 13485, FDA QSR) into actionable QM system elements
Analyze quality and change data to identify trends, systemic issues, and improvement opportunities
Enable Cross-Functional Excellence: Partner with software engineers, data scientists, and product teams on root cause analysis and corrective measures
Coordinate and support internal and external audits (notified body, regulatory authorities)
Facilitate CAPA and change review meetings where diverse perspectives are heard and the best ideas win
Build collaborative relationships across all departments to embed quality thinking everywhere
Foster a Learning Culture: Develop and deliver training programs on CAPA management, change control, and quality processes

What we offer

Join a purpose-driven startup: We are working collectively to fight cancer and improve patient outcomes
Fun, cutting-edge AI research and development, with involvement of Charité, TU Berlin and our other partners
Work with a welcoming, diverse, and highly international team of colleagues
Ability to take responsibility and grow your role within the startup
Competitive remuneration package in addition to perks and benefits
Expand your skills by benefitting from our Learning & Development yearly budget of 1,000€ (plus 2 L&D days), language classes and internal development programs
Mentoring program, where you'll learn from and mentor great experts
Flexible working hours and teleworking policy
Enjoy your well-deserved time off with 30 paid vacation days per year
We are family & pet friendly and support flexible parental leave options

Fulltime

Senior Quality Specialist

Climeworks is a leading high-quality carbon removal provider, combining decades ...

Location

Switzerland , Opfikon

Salary:

Not provided

Climeworks

Expiration Date

Until further notice

Requirements

You hold a degree in Chemistry or Analytical Chemistry
an advanced degree is a plus and strong applied laboratory experience is essential
You bring at least five years of industrial experience in a relevant field such as specialty chemicals, polymers, resins, or advanced materials manufacturing, with a proven track record in quality control and quality assurance
You are confident with material characterization and release testing, for example GC, IC, HPLC, FTIR, TGA, BET surface area, moisture and elemental analysis, and particle size methods, and you choose fit for purpose methods for routine release and investigations
You have deep expertise in method validation and verification, including designing protocols, defining specifications and acceptance criteria, estimating measurement uncertainty and detection limits, and ensuring data integrity across the full data life cycle
You have proven expertise in building and maintaining inspection ready documentation, authoring SOPs, test methods and work instructions, and operating within ISO based quality frameworks in fast growing environments
You are experienced in planning and conducting supplier and manufacturer audits on QC topics, assessing quality systems and measurement capability, gathering evidence, and driving effective corrective and preventive actions through to closure
You work fluently with LIMS and SAP QM for sample management, specification control, results review and release workflows, and you collaborate confidently with suppliers, manufacturers, Procurement, Product Owners and Operations
You communicate clearly and pragmatically in English.

Job Responsibility

You ensure robust quality control and quality assurance for sorbent materials and related QC processes in a dynamic scale‑up environment
You plan and coordinate QC campaigns for sorbents and related materials
You oversee measurements to meet workload and timelines
You review and approve QC data within defined QC specifications and testing standards
You maintain inspection‑ready documentation and records in SAP QM and linked systems
You manage deviations and change controls arising from QC activities and QC‑owned processes
You are responsible for method validation activities
You identify bottlenecks across QC processes and documentation as well as data handling
You act as the QC technical interface to suppliers and manufacturers
You support Procurement with commercial and contractual topics

What we offer

25 paid vacation days every year
public holidays
Hybrid work setup
Up to 4 weeks of remote work annually within any EU country
Fair base pay paired with an equity package
Inclusive parental leave
Dedicated budget to invest in your professional growth
Referral rewards

Quality Assurance Specialist

Amaris Consulting is looking for a Quality Control Supply Chain Specialist to su...

Location

Belgium , Zaventem

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Engineering, Quality Management, Pharmacy, or a related field
4+ years of experience in Quality Assurance, Quality Control, or Supply Chain Quality within regulated industries
Hands-on experience with nonconformance management, CAPA, and root cause analysis
Solid knowledge of Quality Management Systems (QMS) and experience with QM software/tools
Strong analytical skills with experience in data trending, reporting, and Excel
Fluent in English, with a structured, proactive, and detail-oriented working style

Job Responsibility

Supporting international quality assurance activities related to supply chain and distribution processes
Reviewing and approving nonconforming material records, distribution holds, and deviation documentation
Supporting nonconformance management, including root cause analysis and CAPA activities within defined timelines
Reviewing quality documentation related to incoming and outgoing inspections, returns, and shipments
Monitoring and trending quality data, customer notifications, and quality performance indicators
Supporting quality audits, change initiatives, and continuous improvement projects
Ensuring compliance with established QMS procedures and regulatory requirements
Collaborating with internal and external stakeholders to promote quality awareness and process alignment

What we offer

performance bonuses
mobility options including lease cars

SAP Master Data Specialist

Piper Companies is seeking a highly skilled SAP Master Data Specialist to join a...

Location

United States , Gaithersburg

Salary:

70000.00 - 90000.00 USD / Year

Piper Companies

Expiration Date

Until further notice

Requirements

2+ years of experience in SAP data analysis or master data management
Hands on experience with SAP Modules such as MM, PP, QM, MDM, MDG, EWM, etc.
Strong data analysis skills including SQL, Excel (advanced), and data visualization tools
Must have experience working in a GMP/GxP or highly regulated environment
Familiarity with SAP S/4HANA and integrated systems (LIMS, QMS, MES)
Understanding of batch management, master data governance, and data lifecycle controls
Experience with ETL tools, data migration, or system validation
Bachelor’s degree in related field

Job Responsibility

Maintain and manage SAP master data (materials, BOMs, recipes, resources, vendors, batch/lot data) to support GMP manufacturing and supply chain operations
Execute data governance activities, ensuring completeness, accuracy, and compliance with GMP/GxP, 21 CFR Part 11, and internal SOPs
Extract, validate, and analyze large datasets from SAP (HANA/ECC/S4) to support operational insights, CAPAs, deviations, and process improvement initiatives
Collaborate with cross‑functional teams to define data requirements, troubleshoot issues, and enhance SAP workflows and data quality
Develop and maintain reporting dashboards using Power BI, Tableau, SAP BW, or similar tools
Support new product introductions, change control, and part setup/extension processes in SAP

What we offer

Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays

Fulltime

New

Pick Packer Team Member

About the Role: Are you a skilled and reliable Pick Packer looking for a stable,...

Location

Australia , Caboolture

Salary:

Not provided

Metcash

Expiration Date

Until further notice

Requirements

Current Forklift Licence – essential
Previous experience in picking and packing, ideally within a warehouse, trade, or building supplies environment (highly regarded)
Strong attention to detail and ability to work in a fast-paced environment
Physically fit and capable of manual handling (including heavy lifting)
Confident working in active environments and following site safety requirements
A reliable, team-focused attitude with a proactive approach

Job Responsibility

Deliver exceptional customer service, representing Hardings Mitre 10 in a professional manner
Accurately pick, pack, and prepare orders for dispatch, ensuring correct quantities and product quality
Safely load and unload trucks, using forklifts and manual handling where required
Maintain a clean, safe, and organised warehouse, in line with WHS standards
Operate a forklift safely and efficiently

Fulltime

New

Deals and Promotions Coordinator

This is a full-time permanent role responsible for ensuring the accuracy, consis...

Location

Australia , Macquarie Park

Salary:

Not provided

Metcash

Expiration Date

Until further notice

Requirements

Strong Data Entry Skills
Excellent written and verbal communication skills
Strong critical thinking and analytical skills
Previous experience within a data/admin based role
Excellent attention to detail

Job Responsibility

Cultivate strong relationships with the internal ALM teams, serving as a reliable point of contact
Accurately input deal/ promotion information into Metcash core systems within agreed timelines
Regularly review and generate reports to assess the accuracy and completeness of pricing data
Take proactive steps to rectify any inconsistencies or inaccuracies, ensuring a high level of data integrity across all relevant systems
Address inquiries, issues, and concerns promptly and professionally, contributing to overall customer satisfaction
Keep relevant parties informed about deal/ promotions progress, potential challenges, and solutions in a proactive manner

What we offer

5th week of annual leave
2 well-being days
1 volunteer day annually
Endless learning and development opportunities
12 weeks of gender-neutral paid leave for primary carers
Bronze Employer for LGBTQ Inclusion
Gender pay gap under 5%
Gold accreditation by Mental Health Australia
Flex Ready and Family Friendly Workplace accredited

Fulltime

New

State Field Sales Manager

As the Field Sales Manager, you will be responsible for leading, coaching, and d...

Location

Australia , South Fremantle

Salary:

Not provided

Metcash

Expiration Date

Until further notice

Requirements

3-5 years experience in sales, field management, or a related commercial role
Experience managing teams across a distributed geography
Strong leadership and people management skills with the ability to coach, inspire, and develop teams
Excellent communication, relationship-building, and negotiation capabilities
Competence in using sales and reporting tools (CRM, Power BI, Excel etc.)
Intermediate to advanced Excel desirable
FMCG, consumer goods, or foodservice industry experience (highly regarded)

Job Responsibility

Lead, motivate, and mentor a team of Business Development Representatives to achieve sales and execution targets
Conduct regular field coaching visits, providing actionable feedback to enhance capability and performance
Deliver state territory revenue budgets, new customer acquisition targets, and promotional execution objectives
Analyse sales performance, identify opportunities, and implement action plans to improve results
Build strong relationships with larger state customer groups, potential new customers, and regional operations teams
Act as the primary escalation point for store-level issues impacting service, stock, or execution
Manage field team scheduling, route optimisation, and territory coverage to maximise productivity
Oversee reporting accuracy, trade marketing execution, and competitor insights

What we offer

5th week of annual leave
2 well-being days
1 volunteer day annually
Endless learning and development opportunities
12 weeks of gender-neutral paid leave for primary carers
Bronze Employer for LGBTQ Inclusion
Gender pay gap under 5% (WGEA 2024-2025)
Gold accreditation by Mental Health Australia
Flex Ready and Family Friendly Workplace accredited

New

Crane Operator

Are you a skilled and reliable Crane Operator looking for a rewarding role with ...

Location

Australia , Capalaba

Salary:

Not provided

Metcash

Expiration Date

Until further notice

Requirements

Valid driver's licence
Current HR Licence and Crane Operator Ticket – essential
Forklift Licence – essential
Strong communication and interpersonal skills
Physically fit and capable of manual handling (some heavy lifting required)
Confidence delivering to construction and building sites in surrounding areas

Job Responsibility

Safely operate our trucks and crane to deliver products to building sites across the surrounding areas
Provide exceptional customer service while representing Hardings Mitre 10 in a professional manner
Ensure deliveries are completed accurately and on time
Communicate effectively with the team to coordinate deliveries and address any issues promptly
Follow all safety procedures and operational guidelines

Fulltime

Select Country

QM Specialist (CAPA and Change Management)

Aignostics

Location:
Germany , Berlin

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 16, 2026

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