Job description
Quality Assurance (QA) Manager, Logistics America
-Dayton, 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.
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.
The QA Manager ensures compliance of Global Distribution Center US to QMS as well as applicable Standards, Regulations and Guidelines. The position actively support the Americas Logistics organization in the implementation, maintenance, and continuous improvement of the QMS. It also secures Logistics supplier management from Americas QA Logistics standpoint by ensuring approval, performance monitoring, audit when necessary and documentation as per Getinge requirements. The Manager provides partnership and support to Business Area/Sales & Service Unit for Americas Logistics Quality topics. The manager will supervise two Quality Specialists in this role.
Job Responsibilities:
- Manage allocated resources as per position description and operational needs, and as a critical Quality Assurance (QA) representative, lead projects and process improvement affecting Americas Logistics operations.
- Support in establishing, reviewing, improving logistical procedures in QMS
- Support in developing training material and performing training for logistical procedures
- Ensure compliance of Global Distribution Center in the US to Standards, Regulations and Getinge requirements
- Ensure compliant documentation of Quality related activity
- Manage internal audit program
- Support management of Corrective and Preventative Actions (CAPA) related to quality deviation in Americas Logistics.
- Be responsible for the management of State wholesaler licenses, including acting as designated representative for the NJ State license
- Support management of Supplier Corrective Action Requests (SCAR) related to quality deviation in Americas Logistics and suppliers
- Participate in operational/business review meetings with Global Distribution Center in US.
- Support Logistics Operations in the implementation, maintenance, and continuous improvement of the QMS.
- Support Logistics Operations by ensuring monitoring/managing blocked stock.
- Support Logistics Operations in analyzing trends and in identifying improvements.
- Drive or support change to improve and standardize process.
- Support Regional QRC in quality approval and in drafting of quality agreements of warehouses.
- Support Regional QRC in communication, preparation, and follow-up of supplier audits at warehouses.
- Ensure best practice sharing with Regional QRC
- Ensure support to Getinge BA in Quality related activities to be performed at Distribution Center in US.
- Act as Quality representative in implementation of specific/value added activities requested by Getinge BA to be performed at Distribution Center in US.
- Allocate and manage staff resources in line with operations needs
- Ensure People development in line with position description.
- Act as management representative of the Americas Logistics quality management system
- Be responsible for Quality KPI reporting for Distribution Center in US.
- Support or lead Americas Logistics Quality related projects.
- Act as Quality specialist within project affecting Logistics Americas.
The Ideal Candidate Must Have:
- Bachelor in life sciences, logistics or quality management, or an equivalent combination of education and relevant work experience. Master’s Degree considered an advantage.
- A minimum of 7 years relevant experience.
- At least 5 years working experience within the Quality Assurance for Logistics, preferably within medical device industry. Combined experience of Quality and Logistics is required.
- Proven experience managing/supervising others
- Knowledge of ISO 9001, 13485, FDA 21 CFR part 820.
- A strong team player and people manager with strong communication skills.
- Must be able to lead others in the use of critical thinking, problem solving and analysis
- Preferably Lead Auditor Certificate (ISO 9001, ISO 13485).
Base salary for this position ranges from a minimum of $123,000 to a maximum of $168,000 for an experienced candidate. Plus a 15% Short Term Incentive.
Excellent Opportunity to join an industry leader! Excellent Benefits!... Dental, Health, Vision, Life and 401(k) and more!
Interested candidates please send your 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.
INDNM
Job Type: Full-time
Pay: $123,000.00 - $168,000.00 per year
Benefits:
- Dental insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Work Location: One location
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