Quality Control Inspector

499x Siemens Healthineers Endovascular Robotics, Inc.; Elgin (IL); 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 time off

Paid sick time

Job summary

Siemens Healthineers is seeking a Quality Control Inspector to verify electromechanical components and sterile consumables meet design and regulatory standards. The role emphasizes GDP documentation, NCMR handling, and traceability of DHRs across electromechanical assemblies.

The position requires experience with CMMs or vision systems, IPC 610 familiarity, and SAP-based ERP workflows. Applicants should be detail-oriented and able to work overtime in a regulated medical device setting.

Qualifications

• Experience operating under ISO 13485 or ISO 9001 quality systems (medical device manufacturing preferred).
• GDP experience and sterile consumables/documentation requirements.

Responsibilities

• Perform incoming part inspections on electromechanical components and sterile consumables.
• Conduct in-process inspections of assemblies to ensure design and sterile-use compliance.
• Inspect subassemblies and finished products for conformance to specifications.
• Generate and manage Nonconformance Reports (NCMRs).
• Maintain inspection records and GDP-compliant documentation.
• Review Part/Device History Records for traceability of sterile consumables and assemblies.
• Support continuous improvement and investigations across electromechanical workflows.
• Assist with Test Method Validation and inspection method development.

Skills

Incoming part inspections

In-process inspections

NCMRs generation

GDP documentation

DHR traceability

Gage R&R studies

PCB/PCBA inspection

ERP SAP experience

Excel data analysis

Sterile consumables knowledge

Tools

CMM

Optical comparators

Vision measurement systems

ERP systems (SAP)

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 13485 or ISO 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.

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.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• 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

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Affluent Action Employer encouraging diversity in the workplace. 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.

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.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information.

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.”

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.

We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.