Quality Engineer - CARY, NC
Siemens Healthineers · CARY, NC
- Level
- Engineer
- Team
- Quality
- Base pay
- $89k–$123k
- Degree
- Preferred
- Experience asked
- 3+ years
- Industry
- Medical devices
- Posted
- 21 days ago
The role in 30 seconds
An engineer-level quality role at Siemens Healthineers (medical devices) in CARY, NC. 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.
- They ask for
- 3+ years · degree preferred
- Tools it names
- CAPA, ISO 13485, FDA / GMP, Internal audits
- Base pay
- $89k–$123k
Read from the posting. The full description is below.
At a glance
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Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
Responsibilities
- ◆Actively participate in audits and partner with cross functional teams to strengthen quality processes and foster a culture of continuous improvement.
- ◆Act as a key audit lead, conducting internal and supplier audits and partnering with stakeholders to support internal and external audit activities.
- ◆Serve as the CAPA Management Process Manager, owning and overseeing the end ‑ to ‑ end Corrective and Preventive Action (CAPA) process . Lead cross functional CAPA meetings, coach and support CAPA Owners and Quality Managers, moderate CAPA Steering Board meetings , and serve as the C ustomer Services CAPA process subject matter expert during audits.
- ◆Proactively manage assigned process changes to ensure timelines are met, while carefully considering user needs, operational impact, and implementation effort when developing or contributing to process updates.
- ◆Design and continuously improve process related training materials for assigned processes .
Requirements
- ✓A Bachelor’s or M aster’s degree in Q uality , Engineering, Natural Science or a related discipline is preferred, with experience in the medical device industry.
- ✓Minimum 3 years of experience in Quality Management Systems - 5 to 7 years preferred - within a regulated medical device environment in a global acting company .
- ✓Auditor Certification REQUIRED - Lead Auditor certification preferred .
- ✓Expert knowledge of applicable standards (e.g., ISO 13485, FDA 21 CFR QMSR) for medical devices.
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.
EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here .
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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.
As a Quality Engineer, help shape the CS Quality Management System by driving the effectiveness and continuous improvement of CAPA and Document Management process controls.
Capabilities
- •Excellent communication skills, with proven intercultural sensitivity and the ability to collaborate effectively across teams and regions.
- •Excellent decision-making ability, enabling consensus-building across multiple levels of the organization.
- •Customer oriented mindset
- •Ability to develop presentations, tailored to multiple audiences with appropriate levels of detail and focus based on stakeholder needs.
- •Travel required as needed.
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 .