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

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Drexel Hill

Salary:

Not provided

CVS Health

Expiration Date

June 22, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
State-level licensure and national certification requirements vary by state, click here to learn more
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus
Customer Service and Team Orientation
Communication Skills
Mathematical Reasoning

Job Responsibility

Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
Understanding and complying with all relevant federal, state, and local laws, regulations, professional standards, and ethical principles
Delivering additional patient health care services (e.g., immunizations, point-of-care testing, and voluntarily staffing offsite clinics), where allowable by law and supported by required training and certification
Where permissible, the Pharmacy Technician may also support immunizations, which includes the following responsibilities: Completing additional licensure and training requirements, in compliance with state Board of Pharmacy regulations, to obtain Technician Immunizer status to support preparing and administering vaccines
Educating patients about the importance of vaccines and referring patients to the Pharmacist-on-duty for vaccination questions

What we offer

medical, dental, and vision coverage
paid time off
retirement savings options
wellness programs
and other resources, based on eligibility

Fulltime

New

Mri Technologist

MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is see...

Location

United States , Springfield

Salary:

Not provided

MedPro Healthcare Staffing

Expiration Date

Until further notice

Requirements

Completion of a two year approved School of Radiologic Technology
Valid state radiology registration as required by state law
Registry by the American Registry of Radiologic Technology.

Job Responsibility

MRI technologists utilize their knowledge of anatomy, physiology and the principles of MRI to safely and efficiently operate MRI scanners, assisting in the diagnosis of disease and injury.
Ensure the safety of patients, staff and visitors who come in contact with the powerful magnetic field of a MRI scanner.
Position patients and coils on a table that slides inside the MRI scanner.
Inject contrast media as required.
Set appropriate technical parameters, operate MRI scanners and related equipment, and observe image data on computer monitors during scans.
Be familiar with the differences from a normal image and an abnormal image.
Recognize and respond to life threatening situations.
Assure compliance with federal, state, and local technical and professional regulations and accepted practiced guidelines.
Delivers quality, cost effective patient care in a professional manner.
Works effectively to maintain an environment of excellence, which is patient focused, providing timely, compassionate, quality patient care.

What we offer

Weekly pay and direct deposit
Full coverage of all credentialing fees
Private housing or housing allowance
Group Health insurance for you and your family
Company-paid life and disability insurance
Travel reimbursement
401(k) matching
Unlimited Referral Bonuses up to $1,000

Fulltime

New

Pharmacy Technician

We're building a world of health around every individual — shaping a more connec...

Location

United States , Oakville

Salary:

18.94 - 28.94 USD / Hour

CVS Health

Expiration Date

June 23, 2026

Requirements

Must be at least 16 years of age
Licensure requirements vary by state
Attention and Focus
Customer Service Orientation
Communication Skills
Mathematical Reasoning
Problem Resolution
Physical Demands
Visual Acuity
High School diploma or equivalent preferred but not required.

Job Responsibility

manage all assigned pharmacy workstations and tasks to support the team's ability to promptly, safely and accurately fill patient prescriptions
provide caring service that exceeds customer expectations

What we offer

dental
vision
wellness resources
employee discounts
access to certain voluntary benefits

Parttime

New

Cath Lab Registered Nurse

MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is see...

Location

United States , Denville

Salary:

Not provided

MedPro Healthcare Staffing

Expiration Date

Until further notice

Requirements

Active RN License
Degree from accredited nursing program
BLS & ACLS Certifications
Eighteen months of recent experience in an Acute Care Cath Lab setting

Job Responsibility

The Cardiac Cath Lab RN performs angioplasties, implants pacemakers and diagnoses cardiac conditions with an invasive catheterization procedure
Administer care for heart disease and heart attack patients by obtaining visual diagnostics of the arteries of the heart
Identify blockages, assisting the physician during procedures, and monitoring the patient’s status at other times
Administer interventional procedures like cardiac catheterizations, angioplasties, pacemaker and/or defibrillator implantation, and related interventional or diagnostic procedures

What we offer

Weekly pay and direct deposit
Full coverage of all credentialing fees
Private housing or housing allowance
Group Health insurance for you and your family
Company-paid life and disability insurance
Travel reimbursement
401(k) matching
Unlimited Referral Bonuses up to $1,000

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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