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

Spa Host (Male)

Location

United States of America , Kailua-Kona, Hawaii

Salary:

24.79 USD / Hour

Four Seasons

Expiration Date

Until further notice

Requirements

Legal work authorization in United States
Ability to accurately read and work with computer systems
Strong Customer Service skills
Weekend and Holiday availability required
This position is assigned to the MALE locker room area and requires a MALE Host in accordance with applicable law (Bona Fide Occupational Qualification – BFOQ)
Spa experience is preferred

Job Responsibility

Greet all guests with aloha and create and provide a comfortable environment for them while in the Hualalai Sports Club & Hualalai Spa
Provide guests with a thorough knowledge of the sports, fitness and recreational services offered at the Hualalai Sports Club & Hualalai Spa
Provide the Spa Operations Manager(s), Director of Hualalai Sports Club & Hualalai Spa, Director of Operations and/or Manager on Duty information on feedback from guests
Assist management in any way possible to assure the cleanliness, orderliness, and service success of the Hualalai Sports Club & Hualalai Spa and its programs
Responsible for completing and ensuring compliance of all daily opening and closing procedures and assigned maintenance of the following areas
Aerobics Room, Equipment Gym/Fitness Centers, Pool, Attendant Station, Locker Rooms, Operation Center, Basketball, and Volleyball Courts
Responsible for the daily operation and maintenance of the locker room and wet areas of the Spa, fitness areas and gyms according to established protocols and procedures
Offer guests a detailed tour and orientation of the facilities and amenities and assist them as needed during their visit
Prepare aromatherapy cloths and fresh juice and serve guests according to proper service procedures and standards of hygiene
Ensures locker room and outside areas are well-stocked with guest supplies and amenities and ensure high quality presentation of these items

What we offer

Hourly Rate $24.79
An on-site Physical Therapist
24-hour access to Indoor and Outdoor Gym
Holiday, Vacation & Sick pay
Robust Benefit Plan
Company Match 401K Plan
Laundered Employee Uniform
Free employee meals prepared by the Four Seasons Culinary ‘Ohana
Complimentary stays at Four Seasons Worldwide
Training and Development Opportunities

Fulltime

New

Senior Quantity Surveyor (Johor Site)

In this site-based role in Johor, you will manage all post-contract commercial a...

Location

Malaysia , Johor Bahru

Salary:

7000.00 - 10000.00 MYR / Month

Randstad

Expiration Date

July 12, 2026

Requirements

Minimum 5 years of experience in quantity surveying, specifically focusing on post-contract management for high-rise or hotel projects
Strong knowledge of standard forms of contract and Malaysian construction legal requirements
Proven track record in managing complex variation claims and final account settlements
Proficiency in measurement software and financial reporting tools used within the construction industry
Ability to work independently at a project site while maintaining clear communication with headquarters

Job Responsibility

Oversee the administration of main contracts and subcontracts to ensure full commercial compliance throughout the project lifecycle
Manage the valuation of progress claims and the assessment of variation orders to maintain project budgetary control
Lead final account negotiations with subcontractors and consultants to ensure timely project close-out
Monitor project cash flow and prepare comprehensive monthly financial reports for senior management review
Coordinate with the project team to identify potential contractual risks and provide strategic mitigation advice

Fulltime

New

Director Data Privacy

The Director of Data Privacy leads the enterprise-wide data privacy program for ...

Location

United States , SeaTac

Salary:

198450.00 - 307600.00 USD / Year

Alaska Air Group

Expiration Date

May 29, 2026

Requirements

8 years of experience in data privacy, privacy program leadership, regulatory compliance, and privacy risk management
5 years of leadership experience, with at least 2 of those years directly leading people
Demonstrated experience operating in international privacy environments, including GDPR, UK GDPR, and cross‑border data considerations
Hands‑on experience partnering with Technology and Security teams, including privacy‑by‑design, incident response, and integration with security practices
Demonstrated project management experience, with the ability to lead complex, cross‑functional initiatives from concept through execution
Experience selecting, implementing, or operating privacy technology platforms (e.g., consent management, DSR tooling, privacy case management)
Strong understanding of privacy considerations related to AI, automated decision‑making, and advanced data analytics
Demonstrated experience leading privacy incident response, including breach notification analysis, regulatory reporting timelines, data subject notification, and third-party handler accountability
Bachelor’s degree, or an additional two years of relevant training/experience in lieu of this degree
High school diploma or equivalent is required

Job Responsibility

Set and execute the enterprise‑wide data privacy strategy for Alaska Air Group, aligning privacy practices with business priorities, customer expectations, and international expansion
Position privacy as a business‑enabling function, supporting new products, digital experiences, data‑driven decision‑making, and commercial initiatives while managing risk thoughtfully
Partner with leaders across Product, Technology, Commercial, Marketing, HR, and Legal to embed privacy into design, development, and operational processes
Lead enterprise privacy readiness for international and cross‑border operations, including compliance with General Data Protection Regulation (GDPR), UK GDPR, and evolving global privacy regulations
Define and oversee privacy approaches to cross‑border data transfers, working closely with Legal and Security on appropriate transfer mechanisms and safeguards
Provide privacy leadership and input into AI‑enabled and automated decision‑making systems, including guidance on GenAI acceptable use, agentic systems, transparency, fairness, and data subject rights
Oversee and continuously improve the privacy technology stack, including consent management platforms, data subject rights request (DSR) automation, privacy case management, and related tooling to ensure scalable, operational execution
Use customer feedback, preferences, and experience insights to inform data‑use guidelines and influence how personal data is collected, used, and protected across emerging programs
Lead and coordinate responses to privacy incidents and potential data breaches, partnering with Security, Legal, and Communications and representing privacy perspectives at executive levels when required
Prepare executive‑level materials and briefings, including content that supports enterprise leadership and Board‑level discussions through senior leadership

What we offer

Free stand-by travel privileges on Alaska Airlines, Hawaiian Airlines & Horizon Air with high priority status
Select number of confirmed travel credits provided annually
Comprehensive well-being programs including medical, dental and vision benefits
Generous 401k match program
Annual bonus plans
Generous holiday and paid time off

Fulltime

New

Assistant Recreation Manager

Location

United States of America , Maui

Salary:

77604.00 - 85774.00 USD / Year

Four Seasons

Expiration Date

Until further notice

Requirements

Minimum of six months of food & beverage service experience required
Reading, writing and oral proficiency in the English language
Previous supervisory or management experience
Thorough knowledge of service, cost control in F&B, labor controls, menu writing, maintenance and merchandising and accounting
Maui Liquor Card
Hawaii Food Handler's Card
ServSafe (within 3 months)
Tuberculosis Clearance

Job Responsibility

Develop employees through department meetings and time spent together on the floor assisting all job functions and daily duties
Conduct administrative duties, such as scheduling and payroll, using a computer and telephone
Provide accurate information to guests in a courteous manner
fill all reasonable guest requests or requirements
anticipate guest needs

What we offer

Competitive salary & wages
Comprehensive benefits package (Including Medical, Dental, Life Insurance, 401(k), Roth, etc)
Paid time off including Vacation, Sick time, Live Well Day, Community Care Day
Excellent Training and Development opportunities
Learning & Development Subsidy
Many career opportunities within the hotel and to other Four Seasons
Employee Travel Program
Complimentary Dry Cleaning for Employee Uniforms
Complimentary Employee Meal and Paid Meal Break

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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