Manager, Engineering - Quality

ICU Medical Inc.•Salt Lake City, UT

57d

About The Position

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.

Requirements

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, proper negotiation skills and able to work in a team environment.
Acts with urgency and passion in a fast-paced environment. Enjoys helping others.
Good organizational and time management skills with a high level of attention to detail.
Presentation Skills, result oriented. Must be able to relate and communicate effectively to other departments inside and outside of the SLC plant and supervise in an effective manner the performance of resources allocated to the area of responsibility to ensure the required outcome is achieved.
Must be able to relate and communicate effectively to other departments inside and outside of the SLC plant and supervise in an effective manner the performance of resources allocated to the area of responsibility to ensure required outcome is achieved.
Strong oral and written communication skills for effectively interfacing with internal and external areas and plants.
The incumbent will have full responsibility for decisions within normal boundaries. Decisions will naturally be consistent with business objectives, but technical decisions are generally made independently.
The incumbent is expected to develop and effectively administrates his/her portion of projects, resources, and roles responsibilities. The incumbent will routinely encounter conflicting priorities that need timely resolutions and will require constant revision to remain consistent with program objectives and customer delivery commitments.
Follows regulations, norms and procedures. Promptly responds to customer's requests / Customer Focus.
Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, Canadian Medical Device Regulations, ISO 14971 and ISO 13485.
Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.)
Experience writing, reviewing and/or approving quality documents.
Must be 18 years of age
Bachelor's degree in sciences or technical area are required
Minimum 8 years of experience is required; or equivalent combination of education and experience.
2-4 years of management experience
Must be proficient in Minitab or statistical software, Microsoft Excel, Word, PowerPoint, and Outlook

Nice To Haves

Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred.

Responsibilities

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.
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.
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.
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.
Proactively drive continuous improvement activities to ensure problems are prevented and issued resolved efficiently and economically.
Review and approve documentation, including but not limited to Nonconformances, CAPAs and QMS Procedures.
Conducts GMP Training for plant employees to assure employee awareness of their responsibility to GMP compliance.
Assist with Customer, FDA and other regulatory agency inspections as needed.
Recruit, train, lead and mentor direct reports
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.
Be proficient in and make continuous strides towards optimization of inspection methods and sampling.
Working effectively in a team environment with shifting priorities and time sensitive requirements.
Performs other functions as necessary or as assigned.
Work on special projects as they arise