Product Quality Engineer

Job Posted 3 Days Ago Posted 3 Days Ago
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Paoh, Aceh
113K-169K Annually
Senior level
Healthtech • Biotech
The Role
The Product Quality Engineer is responsible for ensuring compliance with production quality standards, implementing quality assurance protocols, and supporting manufacturing operations globally. This role involves collaborating with cross-functional teams to drive continuous improvement initiatives, manage nonconforming products, and uphold regulatory standards.
Summary Generated by Built In

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.

Implements the range of Professional Production Quality standards and concepts according to defined targets and processes.

Varian is seeking a highly skilled and motivated Product Quality Engineer to join our dynamic team. This role will be instrumental in driving innovative solutions to improve production quality, ensuring compliance with regulatory standards, and supporting manufacturing operations locally and globally. You will play a key role in managing cross-functional relationships and transformation initiatives that enhance product quality, performance, and reliability.

**This role is designed to be onsite Mon-Fri 1st shift**

What You will do:

  • Design, implement, and maintain quality assurance and control protocols, standard operating procedures, and methods for inspecting and processing materials, ensuring high-quality production standards.
  • Collaborate with engineering teams to define requirements for automated manufacturing systems, conduct research projects, and identify effective methods for inspecting, testing, and evaluating production processes, equipment, and finished products.
  • Lead and provide engineering support for the evaluation, disposition, and resolution of nonconforming products or processes, utilizing risk-based approaches to ensure production fulfillment.
  • Partner with cross-functional teams to review production schedules, ensuring effective product acceptance based on the Device Master Records (DMR).
  • Actively engage on the manufacturing floor to identify process improvements, drive root cause analyses, corrective action planning, and implementation activities in collaboration with cross-functional teams, leveraging Six Sigma and Lean methodologies.
  • Ensure adherence to internal and external safety, quality, and regulatory standards (e.g., FDA, ISO) by reviewing and approving product and quality system changes with Engineering and Manufacturing.
  • Analyze production data, identify trends, and propose updates to quality standards and procedures through technical investigations, supporting continuous improvement efforts.
  • Support New Product Introduction (NPI) and Design Transfer activities, ensuring smooth transitions from R&D to manufacturing. Lead equipment and process validation efforts, including FMEA, IQ, OQ, and PQ.
  • Take ownership of and/or lead the implementation of equipment calibration programs, including authoring procedures, managing calibration requirements, and advising stakeholders on calibration issues.
  • Act as an advisor to management and business partners, providing guidance on advanced technical areas and supporting decision-making to drive preventive actions and continuous improvement.
  • Participate in relocation projects, ensuring the transfer of key quality documentation (e.g., FMEA, 8D records) and conducting audits for production release.
  • Coach and lead teams on Agile and Lean projects, driving effective project execution and fostering creativity and innovation to improve production quality.

What You will have:

  • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and familiarity with HCM or equivalent ERP systems.
  • Strong problem-solving skills with the ability to perform data analysis using statistical tools and techniques.
  • Knowledge of quality standards and regulatory requirements (e.g., FDA, ISO) and experience in implementing them within manufacturing environments.
  • Experience with Six Sigma, Lean methodologies, and process improvement tools like Value Stream Mapping and PDCA.

Typical Education and Experience

  • Bachelor’s degree (or equivalent experience) and at least 5 years of related experience, or a Master’s degree with at least 3 years of related experience.

If you’re passionate about driving quality and improvement within manufacturing and are eager to make a tangible impact through innovation, apply today to join our team at Varian!

The pay range for this position is $112,700 - 169,000 USD annually; however, base pay offered may vary depending on job-related knowledge, skills, work location, and experience. The annual incentive target is 10% of base pay.  Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.   Details regarding our benefits can be found herehttps://benefitsatshs.com/index.html

Equal Employment Opportunity Statement
Siemens Healthineers is an Equal Opportunity and Affirmative 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.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

Pay Transparency Non-Discrimination Provision
Siemens Healthineers follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here

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

A Successful candidate must be able to work with controlled technology in accordance with US export control law when required. 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.

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. Register here to get started.

#LS-OS1

Who we are: We are a team of more than 73,000 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 Healthineers’ specific businesses, please visit our company page here.

The base pay range for this position is

Min $112,700 - Max $169,000

Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.  

This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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 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. Register here to get started.

Beware of Job Scams: 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.

To all recruitment agencies: 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.

Top Skills

Erp
Hcm
Lean
MS Office
Pdca
Six Sigma
Value Stream Mapping
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The Company
HQ: Palo Alto, CA
10,000 Employees
On-site Workplace

What We Do

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer.

For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 10,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight.

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