Supplier Development and Quality Engineer

Posted 3 Days Ago
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Stockholm, SWE
In-Office
Senior level
Healthtech • Biotech
The Role
Develops and strengthens medical-device suppliers through quality issue management, audits, corrective actions, continuous improvement, supplier approvals, First Article Inspections, PPAP, risk management, and documentation control. Performs quality-control activities for installed Leksell Gamma Knife systems and collaborates with Procurement, R&D, Manufacturing, Service, and suppliers. Requires approximately 10% travel and work in the office four days weekly.
Summary Generated by Built In
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We don’t just build technology. We build hope for everyone dealing with Cancer.

Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.

What You’ll Do At Elekta

As a Senior Supplier Development Quality Engineer, you will help develop and strengthen the supplier base supporting Elekta’s Neuro and Brachy business lines. Working within Business Line Procurement, you will collaborate with suppliers and colleagues across Procurement, R&D, Manufacturing and Service to improve supplier quality, delivery and performance.

You will combine hands-on supplier quality management with audits, problem-solving and continuous improvement. The role also includes quality control activities relating to installed Leksell Gamma Knife systems and approximately 10% travel.

Responsibilities

  • Manage supplier quality issues and ensure effective containment, root cause analysis and corrective action.
  • Monitor and improve the quality performance of assigned suppliers.
  • Conduct supplier approval, surveillance, capability and quality management system audits.
  • Lead supplier development and continuous improvement initiatives using established quality and operational excellence methods.
  • Plan and document Supplier First Article Inspections and Production Part Approval Processes for new or changed parts.
  • Ensure supplier documentation, approvals and Quality Assurance Agreements remain accurate, complete and audit-ready.
  • Apply risk management principles to supply chain, product creation and product change activities.
  • Perform and administer required quality control activities for installed Leksell Gamma Knife systems.
  • Build effective relationships with suppliers and internal stakeholders to support project, quality, cost and delivery objectives.

What You’ll Bring

  • A bachelor’s or master’s degree in engineering, or equivalent relevant experience.
  • At least five years of experience in engineering, manufacturing, supplier quality or supplier development within a regulated industry.
  • Experience conducting supplier or quality management system audits. Lead Auditor certification is an advantage.
  • Knowledge of relevant quality standards and regulations, such as ISO 13485, ISO 9001, ISO 14001, ISO 14971 or 21 CFR Part 820.
  • Experience using structured problem-solving and continuous improvement methods, such as 8D, 5 Whys, Lean or Six Sigma.
  • Strong analytical, communication and stakeholder-management skills.
  • Ability to work independently while contributing effectively within cross-functional teams.
  • Professional written and spoken English; Swedish is an advantage.
  • Willingness to travel approximately 10% of the time.

What You’ll Get

  • 30 paid vacation days per year.
  • Four additional Elekta days off.
  • Defined contribution pension scheme.
  • Private medical insurance.
  • Lunch benefit.
  • Contribution to wellness activities.
  • A collaborative office environment, working alongside colleagues in the office four days per week.

Application Process

We look forward to receiving your application. Please submit your CV in English via the “Apply” button. Applications are reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

Skills Required

  • Bachelor’s or master’s degree in engineering, or equivalent relevant experience
  • At least five years of experience in engineering, manufacturing, supplier quality, or supplier development within a regulated industry
  • Experience conducting supplier or quality management system audits
  • Knowledge of ISO 13485, ISO 9001, ISO 14001, ISO 14971, or 21 CFR Part 820
  • Experience with 8D, 5 Whys, Lean, or Six Sigma
  • Strong analytical, communication, and stakeholder-management skills
  • Ability to work independently and contribute effectively within cross-functional teams
  • Professional written and spoken English
  • Willingness to travel approximately 10% of the time
  • Lead Auditor certification
  • Professional Swedish language skills

Elekta Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elekta and has not been reviewed or approved by Elekta.

  • Retirement Support A 401(k) with employer match is a prominent benefit, with vesting noted as part of the plan.
  • Leave & Time Off Breadth PTO and paid holidays are included, with PTO accruing from the start and rollover allowed within limits.
  • Healthcare Strength Medical, dental, vision, life and disability coverage are included, complemented by an Employee Assistance Program.

Elekta Insights

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The Company
HQ: Stockholm
4,700 Employees
Year Founded: 1972

What We Do

At Elekta, our outcome-driven and cost-efficient solutions provide lasting clinical difference and are developed through sustainable environmental, social and governance practices. We’ve been working openly and proactively with clinicians and our partners for almost half a century to advance precision radiation therapy and meet continuously evolving patient needs—no matter where they are in the world. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with offices in 120 countries and listed on Nasdaq Stockholm.

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