Quality Control Inspector

Siemens Healthineers AG; Newton (MA); On-site; USD 83,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers AG seeks a Quality Control Inspector to ensure electromechanical components and sterile consumables meet regulatory standards. You will inspect mechanical, electrical (PCB/PCBA) and consumable parts, maintain GDP records, and support ISO 13485 quality system compliance.

Responsibilities include incoming and in-process inspections, NCMRs, DHR traceability, and continuous improvement initiatives across electromechanical workflows. Strong attention to detail is essential.

Qualifications

• Must have experience operating under ISO 13485 or ISO 9001 quality systems.
• Proficient in GDP and controlled documentation practices for sterile/medical devices.
• Experience with CMM and PCB/PCBA inspection is strongly preferred.
• SAP experience for tracking components and consumables is advantageous.
• High attention to detail and strict traceability in documentation.

Responsibilities

• Perform incoming part inspections on electromechanical and sterile components.
• Conduct in-process inspections of assemblies for design and sterility compliance.
• Inspect subassemblies and finished products for conformance to specs.
• Generate and manage Nonconformance Reports (NCMRs) as required.
• Maintain inspection records and GDP-compliant documentation.
• Review and maintain DHRs with traceability of sterile consumables and assemblies.
• Support continuous improvement and TMV/inspection-method development.
• Perform other quality-related duties as assigned by management.

Skills

ISO 13485 experience

GDP documentation

CMM inspection

PCB/PCBA inspection

SAP experience

Excel proficiency

Traceability

Attention to detail

Education

Certification: Certified Mechanical Inspector

Tools

Coordinate Measurement Machines (CMM)

Optical comparators

Vision measurement systems

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

The Quality Control Inspector is responsible for ensuring that electromechanical components and single-use sterile consumable components and assemblies comply with company and regulatory standards. Key responsibilities include inspecting mechanical, electrical (including PCB/PCBA) and single-use consumable components and assemblies, while maintaining accurate quality documentation. The role also supports compliance with an ISO 13485–certified quality management system and contributes to safeguarding product quality, patient safety, and continuous improvement in the manufacturing process.

Primary Responsibilities

• Perform incoming part inspections with emphasis on electromechanical components and sterile single use consumable components.
• Conduct in-process inspections of assemblies to ensure compliance with design and sterile-use requirements.
• Inspect subassemblies and finished products, including single-use sterile consumables, for conformance to specifications.
• Generate and manage Nonconformance Reports (NCMRs) as required.
• Generate, review and maintain inspection records and reports in accordance with Good Documentation Practices (GDP).
• Review and maintain Part/Device History Records (DHRs), ensuring traceability of sterile consumables and electromechanical assemblies.
• Support continuous improvement, part investigations, and compliance initiatives across electromechanical and sterile consumable workflows
• Support Test Method Validation (TMV) (i.e., Gage R&R Studies) and Inspection Method development activities.
• Perform other quality-related duties as assigned by management.

Key Requirements

• Demonstrated experience operating under ISO 13485orISO 9001(or equivalent)quality systems (medical device manufacturing environment preferred).
• Proficiency in Good Documentation Practices (GDP) and controlled environment requirements for sterile consumables.
• Experience with Coordinate Measurement Machines (CMM) – tactile and vision-based, strongly preferred.
• Certified Mechanical Inspector (or equivalent) preferred
• Familiarity with applicable standards: ANSI, ASTM, MIL, IEC test methods.
• Skilled in the use of precision hand tools for mechanical and electrical inspection.
• Proficiency with optical comparators and vision measurement systems (e.g., Micro-Vu).
• Ability to measure and verify geometric tolerances in precision electromechanical and consumable parts.
• Competence in interpreting wiring diagrams and PCB schematics for electromechanical devices.
• Prior experience in PCB/PCBA inspection and IPC 610 methods strongly preferred.
• Familiarity with ERP systems for tracking components and consumables (SAP experience strongly preferred).
• Strong working knowledge of Microsoft Office, especially Excel, for data entry and analysis.
• High attention to detail, particularly in maintaining traceability and sterility documentation.
• Ability to work overtime.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Affir... All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

Export Control

A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

The base pay range for this position is: $83,350 - $114,609

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan.
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time.