Collaborate with design and engineering teams to develop and implement quality assurance plans for new products.
Coordinate design for manufacturability activities with design and manufacturing teams to ensure designs are optimized for manufacturability, reducing production costs and improving product quality.
Coordinate and drive design for reliability activities with design teams to ensure designs are suitable to function reliably in the hands of our customers during the intended use and lifetime of the product.
Conduct design reviews and risk assessments to identify potential quality issues and ensure design robustness.
Develop and maintain quality control documentation, including design verification and validation plans, test protocols, and inspection criteria. Ensure all design and quality documentation is accurate, up-to-date, and properly controlled.
Oversee the testing and evaluation of prototypes to ensure they meet design specifications and quality standards.
Perform root cause analysis and implement corrective and preventive actions (CAPA) for design-related quality issues.
Provide quality support during product launches to ensure a smooth transition from development to production.
Ensure compliance with relevant industry standards and regulations, such as

ISO 9001.

Support continuous improvement initiatives by analyzing quality data and implementing process improvements.
Provide training and guidance to team members on quality assurance best practices and methodologies.
Participate in supplier quality management activities, including supplier audits and evaluations. Required Knowledge/Skills/Experience
Bachelor's degree in Science or Engineering discipline, or equivalent combination of education and experience required.
5 years of experience in Quality, Manufacturing or related field in a GMP manufacturing environment specifically including new product introduction/design and development (pharmaceutical industry preferred).
Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and other related regulations.
Certified Quality Engineer, Six Sigma Black Belt, or other relevant certifications preferred
Experience with quality management software required (ETQ Reliance preferred)
Proficient with Microsoft Office Suite.
Cleanroom experience required.
Strong knowledge of design quality assurance principles, methodologies, and tools.
Experience with design verification and validation processes.
Experience with plastics manufacturing (injection molding, 3D printing, etc.)
Familiarity with industry standards and regulations (ISO 9001).
Strong communication and interpersonal skills.
Ability to work effectively in a cross-functional team environment.
Proficiency in quality management software and tools.
Strong self-initiative and the ability to work independently to achieve results
Strong problem-solving and risk-based decision-making abilities.
Strong grasp of manufacturing systems and processes.
Excellent organizational skills and attention to detail.

\nThis is a \"Defined Term\" assignment that will last approximately 6 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.\nSalary range: $115,000- $135,000 annually, depending upon experience #LI-LG1 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. Benefits at

Getinge:

\nAt Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. 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