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

Senior Lecturer/Associate Professor in Literacy

As a Senior Lecturer / Associate Professor in Literacy, you will play a key role...

Location

Australia , Albury-Wodonga, Bathurst, Port Macquarie, Wagga Wagga

Salary:

Not provided

Charles Sturt University

Expiration Date

June 08, 2026

Requirements

A doctoral qualification relevant to literacy or education, with a recognised teaching qualification
A strong record of high-quality teaching and student-centred learning
An established or emerging research profile aligned to literacy, curriculum or pedagogy
The ability to build productive partnerships and contribute to academic leadership

Job Responsibility

Lead impactful literacy teaching and research
Teach across online and on-campus environments
Shape future teachers and education practice
Contribute to curriculum innovation
Build strong relationships with students and partners
Provide academic leadership in literacy education
Contribute to the School's research profile
Supervise higher degree research students
Actively engage with professional, community and government stakeholders
At Associate Professor level: significant academic leadership, research impact, and contribution to the broader discipline at national/international level

What we offer

17% superannuation

Fulltime

New

Program Manager - Controls and Avionics Solutions

This position is based in Endicott, New York. New York and on-site work will be ...

Location

United States , Endicott

Salary:

120874.00 - 205486.00 USD / Year

Baesystems

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, engineering or manufacturing management, or other discipline
Demonstrated ability for building strong customer/ stakeholder relationships
Strong communication, negotiation, and presentation skills
Ability to interpret data and make data-driven decisions
Highly adaptable with strong initiative
Demonstrated ability to lead and motivate cross-functional teams
Knowledge of the global aviation market and regulatory requirements and/ or military aviation market

Job Responsibility

Maintaining strong customer relationships and leading a multidisciplinary team to execute complex development programs within schedule and budget
Leadership and management oversight of a project team assuring that project’s financials, schedule, and technical objectives are met and that the highest level of customer satisfaction is achieved while meeting all contractual commitments
Work effectively and collaboratively with Engineering, Operations, and all Program Office functional leadership to assure deliveries continue to exceed customer commitments and achievement of financial commitments to the company
Manages, coordinates, plans, organizes, controls, integrates, and executes projects within the Military Aircraft Systems portfolio
Participates in the support of new business and in the development of proposals

What we offer

Health insurance
Dental insurance
Vision insurance
Health savings accounts
401(k) savings plan
Disability coverage
Life and accident insurance
Employee assistance program
Legal plan
Discounts on home, auto, and pet insurance

Fulltime

New

Finance Business Partner (Research)

Full Time, Fixed Term (12 months). Level 7 - $101,421 to $110,819 p.a. (plus 17%...

Location

Australia , Wagga Wagga

Salary:

101421.00 - 110819.00 AUD / Year

Charles Sturt University

Expiration Date

June 02, 2026

Requirements

A degree in Accounting or Finance (professional accounting body membership is desirable)
Experience in project budgeting, forecasting and financial analysis
Background in management accounting or business partnering within complex environments
exposure to government funding or higher education is advantageous
Excellent stakeholder engagement skills, with the ability to work effectively with academics and researchers
Familiarity with business intelligence systems and dashboard reporting

Job Responsibility

Partner with academics to deliver strategic financial insights that enable research success
Directly influence world-class projects and decisions shaping the future of education and innovation
Lead initiatives that enhance financial governance, deliver accurate and timely reporting, and support key projects such as cost-pricing systems and research budgeting
Help build financial capability across the University, fostering collaboration and continuous improvement

What we offer

Flexibility with a 35-hour work week
Access to hybrid work arrangements
17% superannuation

Fulltime

New

Associate Lecturer/ Lecturer in Oral Health

Make a real impact by educating future oral health professionals to serve the ur...

Location

Australia , Wagga Wagga

Salary:

80046.00 - 134965.00 AUD / Year

Charles Sturt University

Expiration Date

June 16, 2026

Requirements

A qualification relevant to the discipline and appropriate to the level being applied for
Full registration (for teaching/research) as a Dentist or Oral Health Therapist with the Australian Health Practitioner Regulation Agency (Ahpra)
Excellent understanding of the clinical practice of oral health therapy, supported by a record of teaching and subject coordination relevant to the discipline and appropriate to the level being applied for
Evidence of the delivery of high quality student-centred learning and teaching in oral health therapy and/or general dentistry
A record of research activity or capability relevant to the discipline and appropriate to the level being applied for, as outlined in the position descriptions, may facilitate the progression of research opportunities

Job Responsibility

deliver high-quality teaching, clinical supervision and learning experiences in Oral Health
work with students in both clinical and preclinical settings while contributing to curriculum development, industry engagement and community partnerships

What we offer

Generous support provided to assist with relocating to Riverina’s beautiful Wagga Wagga or surrounds
17% superannuation

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for QM Specialist (CAPA and Change Management)