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Quality Technician III

Company: Getinge
Location: Wayne
Posted on: September 11, 2022

Job Description:

*Quality Technician III **Wayne, NJ**Together we can make a difference!**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. Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels. 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. *Job Responsibilities and Essential Duties*
* Perform destructive and non-destructive testing on in-process and finish goods (e.g. Visual Inspection, Length, Seal width, Water Entry Pressure, Instron Testing, Radial Burst, Borescope).
* Assure timely review and release of Finished Good products (e.g. Cardiac Surgery and Fusion/Fusion Bioline).
* Provide sound judgment on product quality and documentation compliance.
* Sort products by prioritization and schedule/delegate work to the QC Technicians.
* Move non-conforming product to MRB and coordinate the processing of MRB dispositions once they are approved.
* Coordinate the retrieval of historical information for product related concerns to support ongoing investigations (e.g. HHE's & Complaints).
* Assure the timely DHR review and release of Subassemblies and Finished Good products (e.g. Cardiac Surgery and Fusion/Fusion Bioline).
* Approve product that needs to be further processed in the manufacturing areas.
* Review/approve Engineering study and Validation test data prior to submitting to the study coordinator.
* Email, Data Entry, trouble shooting and track product in SAP.
* Coordinate and conduct training of Quality Control Technicians and QC Inspectors on new policies and procedures.
* Work with other lab personnel as a mentor in relation to DHR review, testing and documentation.
* Ability to perform position responsibilities of a QC Tech II, QC Tech III and QC Inspector II as needed.
* Provide feedback of other team members.
* Reads, comprehends and follows job instructions and/or protocols direction including verbal, written and other work related documents.
* Assess priorities and adjust own schedule if needed.
* Generate Certificate of Conformance for released FG material being shipped to countries that require them for importation.
* This is not an inclusive list of job responsibilities. *Required Knowledge, Skills and Abilities*
* High School Diploma or equivalent is required; Associates or BS Degree in Science, Math, Business or related field preferred.
* Member of American Society for Quality (ASQ), Certified Quality Technician (CQT) or Certified Quality Auditor (CQA) is preferred
* Minimum of two years in a quality function and working in a manufacturing environment is required. Three to five years with quality experience in a FDA regulated environment is preferred. Medical device industry a plus.
* Must have Intermediate Algebra, math skills, solid understanding of metric and English systems of measurement and be able to read and comply to part specifications. Must be able to perform math in all units of measure and demonstrate ability to read and interpret documents such as procedures and protocols.
* Instron experience required. Prior training in Series IX, Merlin, or Blue Hill instron operation is preferred.
* Prior training in CE Marking for EU Medical Device Directives, FDA Quality System Regulation; 21CFR Part 820 ISO 13485, and Information Mapping is preferred.
* Must demonstrate effective verbal and written communication skills.
* Must demonstrate ability to work effectively in a team setting, be flexible, and exhibit a willingness to learn/ take on new tasks.
* Must demonstrate ability to identify issues, effectively problem solve, and propose solutions.
* Prior work experience with materials control and specialized testing is preferred.
* Must demonstrate ability to train and coach less experienced technicians and be able to assess and prioritize work in the department.
* Intermediate proficiency with Microsoft Office products or equivalent software application is preferred. Experience with SAP or equivalent system is required. *Excellent Opportunity! Excellent Benefits!... Dental, Health, Vision, Life and 401(k) and more!**For immediate consideration, please submit resume.**_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._* We look forward to receiving your application. 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. We hope you will join us on our journey to become the world's most desired medtech company. INDYA Job Type: Full-time Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Life insurance
* Vision insurance
Schedule:
* Monday to Friday Work Location: One location

Keywords: Getinge, Wayne , Quality Technician III, Professions , Wayne, New Jersey

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