Engineer II, Supplier Quality - Wayne, NJ

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

 

Job Overview

This position is responsible for ensuring the Getinge supply chain provides components, assemblies, and products that meet expected quality levels across Cardiac Assist.  This position will support the Supplier Quality Manager in developing initiatives for continuous improvements to Supplier Quality program in compliance with applicable domestic & international requirements laws, and guidance across Cardiac Assist.

 

Job Responsibilities:

• Oversee processes as a process owner and harmonization of Supplier Quality related processes such as Supplier Management, Supplier-Initiated Changes, SCARs, Getinge Part Approval (GPA), Supplier Audits, etc.
• Lead Mahwah & Fairfield, NJ Supplier Quality Remediation activities.
• Serve as Supplier Quality Lead / SME during internal audits and 3rd party inspections/audits (FDA, BSI, TUV). Oversee audit/assessment of current and potential new suppliers
• Responsible for driving failure analysis and reports on effective corrective actions/supplier corrective action requests (SCARs), NCMR’s and supplier related CAPA’s.
• Manage supplier quality performance results and measurement KPIs.  Enable reporting of metrics for monthly management meetings and management reviews.
• Initiate & Support Supplier Development activities - establish & sustain effective partnerships with suppliers, resolve systemic supplier issues, and develop technical capability.
• Participate in the Part Qualification process. Negotiate and Finalize Quality Agreements such as Supplier Quality Agreement, Service Agreement, Intra-Company Quality Agreement, etc. for supply base spread globally.
• Oversees validations and qualifications of supplier facility to qualify manufacturing processes and overall quality of part/component manufacturing.

 

Minimum Requirements

• Bachelor’s degree in Engineering. 4 years’ experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment.
• Preferred Supplier Auditing Experience.
• Experience of administering Supplier Corrective Action Programs.
• Excellent working knowledge of MS Office (Word/Excel) and a statistical based software package (Minitab preferred).
• Work related travel (Domestic and overseas) 10 – 20 %

 

 

Salary range: $85k - $98k + bonus targeted at 8% based on overall company performance

 

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About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.

 

Benefits at Getinge:

 

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition 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.