- 01-Feb-2017 to 02-Apr-2017 (MST)
- Springville, UT, USA
- Full Time
Medical/Dental/Vision/Life/AD&D/STD/LTD - 401K - PTO and small on site gym.
Senior Quality Assurance Engineer:
ATL Technology is looking for a seasoned Senior Quality Assurance Engineer with the focus on Medical device experience and knowledge.
The Senior Quality Assurance Engineer position will be responsible to lead Quality Control & Quality Assurance activities, oversee the real-time application of the Quality Management Systems (QMS), and assure functional compliance to ISO standards and USA FDA cGMP Regulation. The position will interface with other company locations worldwide including those presently operating in China, Taiwan, and Costa Rica.
The position requires the ability to legally work in USA and to travel internationally including China and Costa Rica to interface with associates, employees, suppliers and customers. The work environment will be a typical office environment for the majority of the time, with up to ten percent of time spent on facility, Customer, or Supplier factory floors to observe or implement manufacturing operations or guide resolution of issues.
Essential Duties and Responsibilities:
Quality Assurance, Quality Management Systems, and Regulatory Compliance
- Be a leading 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
- Lead 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
- Manage the site NCMR & MRB process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results.
- Lead the cross functional engineering teams to apply Process Validation methods based upon Risk Management processes in a Contract Manufacturing environment
- Work with the Utah team to mature and 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 Leadership and Organization:
- Share experience, train less experienced staff, and help identify external training to develop capable team members across multiple functions in product quality processes in product development and launch processes, CAPA, and manufacturing control processes.
- Support customer qualifications, assist hosting on site audits, deliver verification & corrective action results with customers as appropriate; establish and maintain lasting professional relationships.
- Coordinate QMS alignment and improvement activities across locations to assure efficient and proper execution of compliance to ISO13485, ISO9001, ISO 14001, and USA FDA CFR part 820 cGMP.
- Assist in identifying and expanding the core competencies of the site and the organization.
Constructive conflict resolution and Communication:
- Volunteer and perform multiple work assignments relating to QE, QC, and SQE role in a Medical Device Contract Manufacturing environment
- Hold regular status meetings to report on the status and progress of all projects supporting the systems.
- Communicate (and when required, escalate) issues proactively and effectively
- Assure accuracy of technical product and process documentation and revision control throughout the corporation with compliance to full service QMS system
Required skills, education and experience:
- Knowledge of wiring, metal coating plating, contacts and connector designs and materials.
- Engineering experience in the Medical Device Industry
- BS in a technical / scientific discipline such as BSME, BSEE, Physics or similar technical degree
- Clear understanding of the elements of ISO 13485 QMS processes, USA FDA part 820 regulations through at least 10 years of progressive experience
- 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.
- Strong Interpersonal and team building & leading skills required.
- Excellent computer skills (Including, but not limited to: Windows, Office, MiniTab, Visio, MS Projects, and CAD/CAE software tools).
Additional preferred skills and experience that would be considered a plus:
- Experience working with a distributed (multi-site) function or team.
- Postgraduate Degree (MS, MBA)
- Product and process design and development experience with electrical interconnects and/or electromechanical systems, molded plastic parts and precision metal stampings
- Knowledge and experience with Chinese FDA Regulations and cGMP
- Spanish language skills
- Mandarin language skills
- The ability to reduce friction with all levels of internal management and staff.
- An energetic self-starter and team player, who realizes satisfaction from a job well done serving internal and external customers
- Able to manage multiple ongoing projects, trouble-shoot, make suggestions and volunteer or pitch-in as needed to accomplish the goals of the group.
- Understanding the regulatory submission that customers typically go thru while developing and marketing their finished products