Senior Quality Assurance Engineer

4 weeks ago


Detroit, Michigan, United States Getinge Full time
Quality Assurance Role at Getinge

At Getinge, we are committed to making life-saving technology accessible for more people. As a Sr. Quality Engineer, you will play a crucial role in ensuring the effective establishment and maintenance of quality systems. This position is responsible for implementing and executing quality engineering functions, ensuring that quality plans and necessary gap assessments are documented, effective, and completed on time.

Key Responsibilities:

• Supports quality planning by ensuring assigned quality plans and necessary gap assessments are documented, effective, and completed on time.

• Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.

• Supports Supplier management, which includes non-conforming material review and supporting incoming material inspection.

• Coordinates and completes all tasks and documentation required for externally supplied component qualifications (First Article Inspections).

• Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results

• Reviews and approves product/process qualification/validation and other change control related documentation.

• Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.

Requirements:

A Bachelor's degree in Engineering, Science or equivalent is required. A Master's of Science in Engineering, Science or equivalent is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.

A minimum of five years' experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years' experience is required. Prior experience in a FDA regulated industry or ISO certified organization

Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.

Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.

Project management and leadership experience is required. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.

Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.

Knowledge of Microsoft Office Products such as Word, Excel or equivalent software applications is preferred

Compensation:

$100k-$120k + bonus targeted at 10% (depending on overall company performance)

About Getinge:

Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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