We are looking for a Quality Engineer with a great aptitude for learning, being solution driven, and able to focus on both internal and external customer requirements. The ideal candidate will have the opportunity to assist with the growth of our quality department.
Essential Duties and Responsibilities:
Participate as a member of cross functional teams to address advanced quality planning activities in Medical Device Contract Manufacturing environment including Risk Management, ORT, pFMEA, Supplier Selection and Qualification, Inspection Plans, and Control Plans supporting new product launches
Participate as a member on business teams to address Corrective and Preventive Corrective Actions using brainstorming, 5-Why, Cause & Effect and other proven problem solving techniques to deliver problem solving methods to the factory products and processes
Assure consistency of the Product Inspection methods and criteria across the enterprise leveraging statistical techniques and Measurement Systems
Review site CAPA process including formal, effective and detailed reviews to assure the business makes progress in problem solving with verification of corrections and tracking of results.
Participate as a member in the NCMR & MRB process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results.
Participate as a member of cross functional engineering teams to apply Process Validation methods based upon Risk Management processes in a Contract Manufacturing environment
Deliver Customer confidence thru well performing systems with objective evidence of records and Customer Satisfaction thru product and service results,
Participates as a member on Quality team to improve the site Quality Management Systems (QMS) demonstrating compliance to ISO standards and FDA regulations (cGMP) for a full-service site including interfacing with procurement & engineering activities.
Other duties and responsibilities as assigned.
Other Knowledge, Skills, and Abilities:
Significant exposure to REACH, RoHS, WEEE and Conflict Minerals compliance
Experience preparing for and hosting customer and regulatory audits and inspections
Ability to read, analyze, and interpret complex documents.
Ability to respond effectively to the most sensitive inquiries or complaints.
Ability to interface effectively with fellow employees, customers, sales and executive leadership.
BS in a technical / scientific discipline such as BSME, BSEE, Physics or similar technical degree or a equivalent combination of education and experience.
Clear understanding of the elements of ISO 13485 QMS processes, USA FDA part 820 regulations through at least 2 years of progressive experience.
Strong Interpersonal and team building skills required.
Internal Number: 1067796
About ATL Technology LLC
ATL Technology is focused on delivering exactly to our client’s medical industrial, and commercial needs. We are a vertically integrated device manufacturer with the versatility to take on a wide range of projects. Unlike larger companies that have become set in their ways, ATL can change and adapt to our client’s needs in order to create the exact product that they need. Material sourcing, design, prototyping, production, and manufacturing are some of the services that our experienced engineers and staff are can provide. We offer every service necessary so that our clients know the best work goes into the project.