Sr. Quality Engineer

vor 1 Tag

Neuenburg, Schweiz Aktiia Vollzeit

At Aktiia, we believe the key to improving cardiovascular health is to provide patients and physicians with a deeper understanding of the blood pressure pattern. Before Aktiia, it was not possible to monitor cardiovascular health at scale.

We are an early-stage, venture-backed start-up that has raised over $40M from top-tier investors in Europe and the United States. We have developed and brought to market the world’s first continuous blood pressure monitor. Our technology is based on 15 years of research by our founders at the prestigious Swiss Center for Electronics and Microtechnology (CSEM). Aktiia's solution has been validated through extensive clinical trials and received a CE Mark as a Class IIa medical device under MDR leading to commercial access of approximately 43 countries worldwide.

To strengthen our team, we are seeking a highly motivated Sr. Quality Assurance Engineer with experience in operations, logistics, and manufacturing (complaints handling is a plus):

This position must provide expertise and leadership in the areas of corrective and preventive action, manufacturing process controls, supplier management, QMS process assurance, quality system requirements, and process monitoring. This position will work with Development, Operations, Manufacturing, and other Quality functional areas to ensure work is completed in accordance with internal procedures and medical device regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.

Responsibilities:
  • Partner with manufacturing team to lead/support quality engineering activities with contract manufacturers (IQ, OQ, PQ support, non-conformance resolution, process validations, test method validations).
  • Lead cross-functional teams to resolve quality issues and navigate the CAPA process.
  • Resolve manufacturing non-conformances with contract manufacturers. Approve DHRs, DHF deliverables, product releases and change orders.
  • Coach manufacturing personnel and contract manufacturers on GMP and QMS requirements for medical device manufacturers.
  • Lead projects to drive product improvement and increase operational efficiency at the direction of quality management.
  • Support internal labeling reviews to ensure required markings and symbols are present on product labels and in the user manual.
  • Lead supplier management activities (e.g., supplier audits, qualifications, assessments).
  • Support QMS audits with both internal and external auditors.
  • Document product-related vigilance reports within the required timelines and provide any necessary documents required to complete the investigation.
Minimum Requirements:
  • Bachelor’s degree in a technical or scientific field.
  • 5 - 8 years minimum experience in a quality or manufacturing function in the finished medical device industry.
  • Demonstrate team leadership skills and ability to independently prioritize, execute and report on projects.
  • Knowledge on ISO and FDA/Quality System Requirements (e.g., MDR; ISO 13485; ISO 14971; FDA 21 CFR Part 820).
  • Strong project and time management skills.
  • Familiar with Risk Management as governed by ISO 14971 (e.g., process FMEA).
  • Demonstrate creative and effective problem solving for resolving complex issues.
  • Ability to work on multiple tasks concurrently with changing priorities.
  • Proficient with MS Teams, Word, Excel, PowerPoint, and eQMS systems.
Additional Information:
  • Competitive compensation package based on experience.
  • Flexible work location (hybrid work schedule) and occasional international travel as required (10% of time).

We look forward to receiving your application on the platform or at aktiia@jobs.workablemail.com.

#J-18808-Ljbffr

  • MS Process Engineer

    vor 2 Monaten

    Neuenburg, Schweiz CK Group Vollzeit

    MS Process EngineerCK QLS are looking for a senior process engineer to join a global pharmaceutical company, based in Neuchatel, on a contract basis for 12 months.Position: MS Process Engineer Formulation, Fill and Finishing, NeuchatelDuration: 12 monthsMain Responsibilities:Manufacturing support activities (deviation, process follow-up) - 45% of the...

  • Analog IC Design Engineer

    Vor 4 Tagen

    Neuenburg, Schweiz IC Resources Vollzeit

    1 day ago Be among the first 25 applicantsAnalog IC Design EngineerI am recruiting for a reputable organisation near Neuchâtel, Switzerland, who are looking for an experienced Analog IC Design Engineer to join their sensor design team.Responsibilities:Collaborating within the team to design and develop sensor ICs.Taking a hands-on approach to the technical...

  • CAD Layout Engineer

    vor 2 Monaten

    Neuenburg, Schweiz Microtech Global Ltd Vollzeit

    Position:CAD Layout EngineerLocation:Neuchatel, SwitzerlandEmployment:PermanentCompany Overview:My client’s “Integrated & Wireless Systems” Business Unit based in Neuchâtel, Switzerland, is currently looking for CAD Layout R&D Engineer.About the company's mission and values:Their mission is the development and transfer of innovative technologies to...

  • Senior Process Engineer

    vor 2 Wochen

    Neuenburg, Neuenburg, Schweiz CK Group Vollzeit

    We are seeking a highly skilled Senior Process Engineer to join our team in Neuchatel, Switzerland. As a key member of our team, you will be responsible for leading process improvement projects, developing and optimizing process parameters, and ensuring process performances through Quality by Design (QbD) and Continuous Process Verification (CPV)...

  • Software Engineer

    Vor 4 Tagen

    Neuenburg, Schweiz Pouly Tradition Vollzeit

    We are seeking a highly skilled and experienced Software Engineer to join a dynamic team in Neuchâtel. This role is integral to industrial operations, focusing on both software development and automation tasks aligned with Industry 4.0 standards.The client is an industrial company.DescriptionDevelop, maintain, and debug industrial software solutions.Ensure...

  • Reliability Engineer

    Vor 4 Tagen

    Neuenburg, Schweiz Experis Switzerland Vollzeit

    Description: The job title for this role is: Reliability Engineer Facilities and Utilities Responsibilities: Improving the reliability of equipment, critical systems, and maintenance processes by applying the principles of Reliability Engineering program. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a...

  • Engineer Manufacturing Compliance

    vor 1 Woche

    Neuenburg, Schweiz Gi Group Vollzeit

    Direct message the job poster from Gi Group For our partner in the Pharmaceutical industry, in the Canton of Neuchâtel, Gi Life Sciences is looking for an: Engineer Manufacturing & Compliance (Temporary contract) Your mission: This role will support the Head of Packaging Operations in monitoring quality and performance metrics while acting as a referee for...

  • Quality Engineer

    vor 3 Monaten

    Neuenburg, Schweiz Safran Vollzeit

    Dans ce poste vous serez responsable de développer et maintenir une culture basée sur les responsabilités individuelles, l'amélioration continue et le respect des procédures et processus organisationnels. Description du poste Piloter des projets d’amélioration continue sur différentes thématiques, y compris techniques Assurer le support Qualité...

  • Software Engineer

    vor 1 Monat

    Neuenburg, Schweiz Michael Page International (Switzerland) SA Vollzeit

    About Our ClientThe client is an industrial company.Job DescriptionDevelop, maintain, and debug industrial software solutions.Ensure the software meets high standards of quality and performance.Collaborate with cross-functional teams to design and implement new features.Work on automation projects to enhance industrial processes.Implement and optimize...

  • MS Process Engineer

    vor 2 Wochen

    Neuenburg, Schweiz Aristo Group Vollzeit

    Direct message the job poster from Aristo GroupMSP Lead | MSP Partnering at Aristo Group | Empowering Life Science with the Perfect MatchJob title: MS Process Engineer (Fill and Finish) (m/w/d)Skills: MS Process EngineerStart of project: asapDuration of the project: 12 monthsPrimary ResponsibilitiesLead process improvement projects and optimize process...

  • CSV and IT Compliance Engineer/Manager

    vor 1 Tag

    Neuenburg, Schweiz gloor & lang Pharma and Biotech Recruiting Vollzeit

    4-6 months contractor – FRENCH Speaking necessaryOur customer is an innovative biopharmaceutical Big Pharma company. For an on-site assignment for the brand new commercial manufacturing site, we are looking for 2 experts in CSV for the Pharma Industry.As part of their continuous growth, our client is implementing new IT systems at their local manufacturing...

  • Software Engineer

    Vor 4 Tagen

    Neuenburg, Schweiz Michael Page International (Switzerland) SA Vollzeit

    About Our Client The client is an industrial company. Job Description Develop, maintain, and debug industrial software solutions. Ensure the software meets high standards of quality and performance. Collaborate with cross-functional teams to design and implement new features. Work on automation projects to enhance industrial processes. Implement and...

  • CSV and IT Compliance Engineer/Manager

    Vor 4 Tagen

    Neuenburg, Schweiz gloor&lang AG Vollzeit

    4-6 months contractor – FRENCH Speaking necessaryOur customer is an innovative biopharmaceutical Big Pharma company. For an on site assignment for the brand new commercial manufacturing site we are looking for 2 experts in CSV for Pharma Industry.As part of their continuous growth, our client is implementing new IT systems at their local manufacturing and...

  • Senior MS&T Engineer

    vor 2 Wochen

    Neuenburg, Schweiz BioTalent Vollzeit

    2 days ago Be among the first 25 applicantsDirect message the job poster from BioTalentSenior Consultant - Key Account Management at BioTalent, part of The IN Group | R&D within Life Sciences - UK/EU/USPermanent - full-timeAre you a seasoned professional in the pharmaceutical industry looking to take your expertise to the next level?BioTalent have teamed up...

  • MS Process Engineer Formulation, Fill and Finishing

    vor 4 Wochen

    Neuenburg, Schweiz Randstad (Schweiz) AG Vollzeit

    Job DescriptionFor our client, an international pharma company based in Neuchâtel, we are looking for an MS Process Engineer Formulation, Fill and Finishing.General Information:Start date: 06.01.2025End date: 31.12.2025Workplace: NeuchâtelWorkload: 100%Home office: possible up to 3 days per week, but during the first 2-3 weeks onsite presence required full...

  • Validation Engineer

    vor 1 Woche

    Neuenburg, Schweiz LHH Vollzeit

    I am looking for my client, a medical device manufacturer based in the canton of Neuchatel, for a Validation Engineer for a temporary (long term) contract.Your responsibilities:Generation and execution of qualification/validation protocols including the generation, routing, and approval of summary documentation.Work with project teams to develop DOEs and...

  • CAD Layout R&D Engineer

    vor 1 Woche

    Neuenburg, Schweiz CSEM SA Vollzeit

    Facing the challenges of our time Help us grow and be more impactful ! Our “Integrated & Wireless Systems” Business Unit based in Neuchâtel, Switzerland, is currently looking for CAD Layout R&D Engineer.Mission As a CAD Layout R&D Engineer, you will be played an important role within SwissChips initiative to boots Swiss chip industry. You provide highly...

  • CAD Layout R&D Engineer

    vor 1 Tag

    Neuenburg, Schweiz CSEM Vollzeit

    Share this job offerFacing the challenges of our timeHelp us grow and be more impactful!Our “Integrated & Wireless Systems” Business Unit based in Neuchâtel, Switzerland, is currently looking for CAD Layout R&D Engineer.MissionAs a CAD Layout R&D Engineer, you will play an important role within the SwissChips initiative to boost the Swiss chip industry....

  • Process validation engineer

    vor 1 Woche

    Neuenburg, Schweiz Antaes Consulting Vollzeit

    Direct message the job poster from Antaes ConsultingTo join our Life sciences team in Neuchâtel, we are looking for a MSAT Validation Senior Scientist (F/M).Your Role :Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with...

  • Digital IC Design Engineer

    vor 3 Monaten

    Neuenburg, Schweiz Michael Page International (Switzerland) SA Vollzeit

    Global Semiconductor Leader - Electric Vehicles Industrial AutomationFPGA Prototype - RTL Design - RISC-V - SoC - Team MentorshipAbout Our ClientWhy Join our client's Design Hub in Neuchatel?Operates across 20+ manufacturing sites globally, including a strong presence in Europe, Asia, and North America.Is recognized for its leadership in automotive and...