Sr. Engineer, Quality CA

With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Getinge is a global company that designs and manufactures medical devices and life science equipment. We are committed to reducing our environmental impact both in our own operations and across the value chain. We operate with a global perspective on sustainability guided by the precautionary principle and in collaboration with our key stakeholders. Our key initiatives and principles are Greenhouse emissions, Resource efficiency, Circularity and Eco-Design. We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.
We currently have an open position for a Sr. Quality Engineer. This position is r esponsible for implementation and execution of Quality Engineering Function, ensuring the effective establishment and maintenance of quality systems.
Key Job 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.
• Investigates product issues by conducting failure investigations, complaint trending, and Product Inquiries.
• Investigates component issues by conducting failure/root cause investigations and conducts product inquiry reports (PIR), as needed.
• Communicates, interacts and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations and problems; provides testing and training support to Manufacturing, Engineering and R&D.
• Supports the Material Review Board by providing or reviewing the disposition of Nonconforming Material.

Required Knowledge, Skills and Abilities

• 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

Salary: $100k-$120k + bonus targeted at 10% (depending on overall company performance)
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About us
With a firm belief that every person and community should have access to the best possible care, 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.