Senior Quality Engineer, New Product Introduction

Reposted 8 Days Ago
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Arroyo
Junior
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The role involves supporting design and testing of new products, ensuring quality standards, risk identification, and collaboration with engineering and manufacturing teams.
Summary Generated by Built In
Work Flexibility: Hybrid

What you will do:
  • Support the design and testing of new products.

  • Ensure that everything functions well and meets quality standards.

  • Identify and prevent potential problems (especially risks, defects, and inspection issues).

  • Ensure the product can be manufactured efficiently and safely.

  • Support validations (process, tool, and equipment testing).

  • Assist in the selection and approval of suppliers for new components or processes.

  • Lead quality activities during design transfer (when the product moves from design to production).

  • Work closely with engineering and manufacturing teams to ensure product quality and manufacturability.

What you will need:

Required:

  • University degree in engineering (or similar).

  • At least 2 years of experience in regulated industries, such as medical devices or pharmaceuticals.

  • Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections.

  • Knowledge of standards such as ISO 13485 (quality standard for medical devices).

  • Advanced English communication skills (oral and written).

Desirable:

  • Experience with Process Flow Mapping (PFM) or process risk assessment.

  • Experience with non-conformity management.

  • Experience with supplier quality initiatives.

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Top Skills

Capa
Fmea
Iso 13485
Ppap
Process Flow Mapping
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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