Manager, Engineering - Quality

Responsible for coordinating and managing a quality engineering team focused on hands-on quality support for prevention and/or early detection of product quality events ensuring proper evaluation and resolution while maintaining compliance to regulatory requirements and procedures

This role administrates the overall site Nonconforming, Supplier Quality and CAPA processes to ensure procedures for identification, evaluation, disposition, investigation, actions implementation, effectiveness verification, track and trending and adequate documentation are followed to help address quality issues impacting product as reported by internal processes, sister facilities and customers. The incumbent will monitor quality KPI trends and is an activist and mentor of the use continuous improvement initiatives, statistical techniques and root cause analysis tools to achieve a high level of product and service quality for the customers.

The position requires good knowledge on the disciplines within a medical device Quality Management System (QMS) and knowledge and understanding of manufacturing and quality control processes. The incumbent can guide multidisciplinary teams internal and external for proper and timely resolution of quality problems at any point during the product lifecycle. This position will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards.

The person in his role must have good communication and leadership skill with level of manager influence to coach a team of engineers and the ability to plan, multi-task in a fast-paced environment and manage time effectively to ensure activities associated to the role are properly accomplished to avoid regulatory risk. 

Collaborate with other internal and external quality, operation and technical functions to lead and support initiatives around improving product quality and processes performance with customers and overall QMS compliance level for the Salt Lake City facility.

Essential Duties & Responsibilities 

1. Lead and coach the Manufacturing Quality Engineers and ensures appropriate quality engineering structure are in place to meet quality expectations and business needs to support product lifecycle.
2. Implement quality engineering tools in the operation to drive methodical and process-based approaches to product and process improvements. Have the ability to methodically process and investigate in a high paced, efficient and accurate manner.  Use quality toolbox including six sigma methodology, lean principles, and when appropriate use advanced statistics and other proven tools. 
3. Partner with Engineering, Maintenance, Production, Quality Operation and other functions to get prompt resolution and prioritization of tasks around quality problems for product and processes and to drive the highest quality results. 
4. Manage oversight, document and approve nonconformances (product and non-product related) in a timely manner and serves as an activist and mentor in problem solving and root causing activities. 
5. Proactively drive continuous improvement activities to ensure problems are prevented and issued resolved efficiently and economically.
6. Review and approve documentation, including but not limited to Nonconformances, CAPAs and QMS Procedures.
7. Conducts GMP Training for plant employees to assure employee awareness of their responsibility to GMP compliance.
8. Assist with Customer, FDA and other regulatory agency inspections as needed.
9. Recruit, train, lead and mentor direct reports 
10. Assists the Site Quality Leader in the developing, recommending and implementing of section and departmental goals and objective policies, budgets and plans for defining the effective utilization of the Quality Organization resources.
11. Be proficient in and make continuous strides towards optimization of inspection methods and sampling.
12. Working effectively in a team environment with shifting priorities and time sensitive requirements. 
13. Performs other functions as necessary or as assigned.
14. Work on special projects as they arise

Knowledge, Skills & Qualifications

• Practical knowledge on handling Nonconformance, CAPA, Complaints and/or Supplier Quality Processes for regulated industry.
• Ability to influence others with leadership, proper negotiation skills and work and in a team environment. 
• Acts with urgency and passion in a fast-paced environment. Enjoy helping others.
• Strong analytical, problem solving and decision-making skills.
• Able to make decisions, set priorities and complete projects and tasks with minimum supervision.
• Able to influence others at all levels within the organization using right leadership approach,