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

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

Vice President

iCapital is looking to hire an investment product specialist Vice President to s...

Location

China , Hong Kong

Salary:

Not provided

iCapital Network

Expiration Date

Until further notice

Requirements

10+ years of experience working within the alternative investment industry in a client facing capacity (e.g., Investor relations at GPs or distribution specialist at placement agents, fund of funds and asset management firms with alternative investment product experience)
A self-starter who demonstrates the ability to work in a fast-paced entrepreneurial environment and follow a rigorous sales process
Strong team orientation with exceptional organizational and interpersonal skills especially in a cross-boarder and small team-working environment
Strong with Microsoft powerpoint and has excellent verbal and written communication skills
Local regulatory licensing is required
Relevant language skills is a plus

Job Responsibility

Leverage a consultative sales process to acquire new relationships, expand existing client relationships, and service assets under management
Develop high level of sales proficiency with iDirect offerings in private equity, private credit, and hedge funds and other future iDirect products and a good understanding of the asset class as well as product comparison purposes
Traveling is required to markets to meet with gatekeepers, advisors, industry bodies, end clients in support of the broader sales and educational effort
Assist in the planning and execution of roadshows and conferences
Work alongside the in region Client Solutions team personnel on client pitches, product positioning, and sales campaigns
Leverage technology input and reporting tools to support sales management activities

Fulltime

Customer Assistant II

Location

United States , Amherst

Salary:

26.06 - 29.33 USD / Hour

Massachusetts Municipal Association

Expiration Date

Until further notice

Requirements

High school degree or equivalent PLUS one to three years of experience in accounting, bookkeeping, or cash handling
OR any equivalent combination of related education and experience that demonstrates the ability to successfully perform the responsibilities of the position

Job Responsibility

Perform a full range of complex procedural accounting and clerical duties associated with computation, reconciliation and posting to accounts for town collection areas (e.g., Water and Sewer, Parking)

Fulltime

Care Assistant - Days

Are you ambitious? Do you want something else? Are you looking for new energy? W...

Location

United Kingdom , Poynton

Salary:

12.75 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

No previous experience or qualifications needed
Enhanced DBS check in relation to Children and Adults required

Job Responsibility

Support with personal care needs
Help residents take part in a wide range of special interests and activities that support their health and wellbeing such as arts and crafts, watching the footie, drama, musical evenings, gardening, shopping trips and social occasions

What we offer

Discounts on Shopping, Fashion, Days out, Travel, Entertainment and lots more
Flex Earn – Earned wage access
FREE face-to-face counselling for you and your family
Staff recognition award ceremonies
£30 voucher available every month for the nominated Employee of the month
Opportunities for training and career progression
Salary Sacrifice Pension scheme
Blue Light Card – up to 50% discount across 100’s of retailers
Access to a FREE eye test and discounted glasses
Cashback card – save up to £500 annually

Fulltime

DPW Highway Equipment Operator

The town of Littleton is seeking qualified applicants for a full-time 40-hour/we...

Location

United States , Littleton

Salary:

24.56 - 29.54 USD / Hour

Massachusetts Municipal Association

Expiration Date

July 17, 2026

Requirements

Valid driver's license
CDL class B
Hoisting license 2B/1C minimum (or ability to obtain within 12 months)
Ability to operate heavy equipment, riding mowers, snow and ice equipment, power and hand tools
Snow and ice operations, drainage system experience and roadway construction knowledge preferred

Job Responsibility

Perform routine work assisting in all Public Works construction, maintenance and repair projects
Operate heavy equipment, riding mowers, snow and ice equipment, power and hand tools

What we offer

On call standby stipend
Winter standby stipend
Licenses and clothing stipends per union contract
Overtime available

Fulltime

!

Grant Accountant

We are looking for a detail-oriented Grant Accountant to join our team in Vernon...

Location

United States , Vernon

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience managing grant accounting activities, including budget tracking, reporting, and compliance oversight
Knowledge of government grant requirements and nonprofit accounting practices, including restricted fund management
Ability to prepare reconciliations, journal entries, and financial analyses related to grant-funded operations
Familiarity with revenue recognition principles and month-end close processes tied to grants
Proficiency with grant management and fund administration in an accounting environment
Experience working with Abila MIP or similar nonprofit accounting software
Strong analytical skills with the ability to interpret budget variances and maintain accurate financial records

Job Responsibility

Oversee grant budgets, spending activity, and funding balances to help maintain accurate financial control across active awards
Review transactions to confirm costs are properly assigned, permitted under grant terms, and aligned with applicable funding requirements
Prepare grant-specific financial schedules, account reconciliations, and supporting documentation for internal review and external reporting
Develop and submit financial reports for grantors based on required deadlines, formats, and compliance expectations
Support audit activity by organizing records, responding to documentation requests, and assisting with grant-related testing and reviews
Partner with program leaders to build grant budgets, evaluate spending trends, and explain budget-to-actual differences
Record journal entries and maintain general ledger accuracy for grant revenue, expenditures, and fund classifications
Distinguish restricted and unrestricted funding appropriately to support proper accounting treatment and financial reporting
Collaborate with development and program teams to provide financial guidance on proposals, reporting obligations, and allowable use of funds

What we offer

Medical insurance
Vision insurance
Dental insurance
Life insurance
Disability insurance
401(k) plan
Deferred compensation plan
Paid time off for vacation, personal needs, and sick time
Paid holidays

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QM Specialist (CAPA and Change Management)

Job Description

Job Responsibility

Requirements

What we offer

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