Quality Control Inspector

Regulatory Jobs; United States; 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 is seeking a Quality Inspector to support incoming and in-process inspections of electromechanical assemblies and sterile consumables. You will generate NCMRs, maintain DHRs, and contribute to GDP-compliant records and continuous improvement efforts.

The role requires experience with ISO quality systems, GDP, CMM/vision-based inspection, and IPC 610 methods, with SAP and Excel proficiency. Overtime may be required.

Qualifications

• Experience in ISO 13485 or ISO 9001 quality systems in medical device manufacturing.
• Proficiency with GDP and sterile consumables documentation.
• Strong knowledge of CMM tactile/vision-based inspection.
• Certified Mechanical Inspector or equivalent preferred.
• Familiar with ANSI/ASTM/MIL/IEC test methods.
• Proficient with precision hand tools for inspection.
• Experience with optical comparators and vision systems (Micro-Vu).
• Ability to measure and verify geometric tolerances on electromechanical parts.
• Ability to interpret wiring diagrams and PCB schematics.
• Experience with PCB/PCBA inspection and IPC 610 methods.
• ERP/SAP experience strongly preferred.
• MS Office Excel for data entry and analysis.
• High attention to detail for traceability and sterility documentation.
• Ability to work overtime.

Responsibilities

• Perform incoming part inspections with emphasis on electromechanical components and sterile single use consumables.
• 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 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) and Inspection Method development activities.
• Perform other quality-related duties as assigned by management.

Skills

ISO 13485/9001

GDP & documentation

Attention to detail

Traceability

Wiring/PCB interpretation

Quality inspection

Tools

CMM tactile/vision

Vision systems (Micro-Vu)

Optical comparators

ERP SAP

IPC 610 methods

Excel

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.

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.

To find out more about Siemens Healthineers businesses, please visit our company page here.

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 affirmational 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. 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.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information. To learn more, click here.

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. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

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Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

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Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.