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

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We are looking for a detail-oriented Billing Clerk to support a fully remote bil...

Location

United States , Houston

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

At least 2 years of experience in billing, invoicing, or a closely related clerical accounting function
Hands-on experience with computerized billing systems in a detail-focused work environment
Working knowledge of Microsoft NAV for billing or financial record support
Intermediate Microsoft Excel skills, including the ability to review and manage data accurately
Ability to work a Monday through Friday schedule aligned with Hawaii-Aleutian Standard Time
Strong attention to detail with the ability to identify inconsistencies and correct errors efficiently
Effective communication and time management skills to succeed in a fully remote position

Job Responsibility

Review billing tickets carefully to confirm accuracy, completeness, and readiness for processing by the onsite billing team
Verify billing-related details and resolve discrepancies before records move forward in the invoicing workflow
Maintain organized billing documentation and update information within the billing system as needed
Use Microsoft NAV to support daily billing activities, track records, and confirm transaction data
Prepare and check billing statements to help ensure timely and accurate processing
Work closely with internal team members in a remote setting to address questions and keep billing tasks on schedule
Apply Excel skills to review data, compare entries, and support routine reporting or reconciliation tasks

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

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Location

United States , White Plains

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree in Accounting, Finance, or related field
CPA or CPA-track preferred
Minimum 5-7 years of accounting experience, with at least 3 years in a nonprofit environment
Strong understanding of GAAP, fund accounting, and restricted revenue
Advanced proficiency in Excel
experience with Blackbaud, QuickBooks, Sage Intacct, or similar systems
Excellent analytical, organizational, and communication skills
Ability to manage multiple priorities and meet deadlines in a fast-paced environment
Commitment to the mission and values of the organization

Job Responsibility

General Ledger Oversight — Maintain and reconcile all GL accounts, ensuring accuracy, completeness, and compliance with GAAP and nonprofit standards
Month-End Close — Lead monthly closing activities, including journal entries, accruals, allocations, and reconciliations
Financial Reporting — Prepare internal and external financial statements, dashboards, and management reports
Grant & Contract Accounting — Track restricted funds, prepare grant budgets, monitor spending, and ensure compliance with federal, state, and private funder requirements
Budget Development — Support annual budgeting and periodic forecasting
collaborate with program leaders to analyze variances
Audit Preparation — Serve as a primary liaison during annual audits
prepare schedules, documentation, and reconciliations
Accounts Payable & Receivable Oversight — Review AP/AR transactions, ensure proper coding, and maintain vendor and donor records
Cash Management — Monitor cash flow, prepare cash projections, and reconcile bank accounts

What we offer

medical insurance
vision insurance
dental insurance
life and disability insurance
401(k) plan

Fulltime

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Location

Japan , 東京23区

Salary:

8000000.00 - 20000000.00 JPY / Year

Randstad

Expiration Date

September 30, 2026

Requirements

7+ years of implementing and managing SAP ERP solutions, with a strong focus on SAP S/4HANA experience
Experience in building profitable partner ecosystems
5+ experience in selling SAP solutions, co-selling with SAP and negotiating with SAP for a win-win deal pursuit across value, technical architecture and commercials

What we offer

健康保険
厚生年金保険
雇用保険
ボーナス・ストックオプション支給
土曜日日曜日祝日

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Make a difference while having fun. Help kids build confidence, reach milestones...

Location

United States , Plainfield

Salary:

15.00 - 16.75 USD / Hour

Goldfish Swim School

Expiration Date

Until further notice

Requirements

Comfortable working with children
Strong communication and teamwork skills
Basic swim ability (competitive experience not required)
Lifeguard/CPR certification preferred (training provided)
Ability to pass a background check

Job Responsibility

Teach and support children in swim lessons
Ensure safety in and around the pool
Work as part of a positive, energetic team

What we offer

Flexible hours (great for students)
Paid training
Opportunities for growth and leadership
Fun team events, rewards, and recognition
Valuable experience and future references

Parttime

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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