Position Summary
The Senior Manager, Quality Operations will be responsible for developing, directing, coordinating and managing quality control, calibration, metrology, biological quality and sterilization functions and programs at the Salt Lake City Facility. This role oversights all quality controls activities from raw material reception to final release of products and ensures compliance to applicable procedures, industry standards and regulations for all processes involved in the inspection of molded, sub assembled and finished medical devices including the responsibility to ensure existing testing and measurement systems in place are suitable to the application where they are used and that clean room, sterilization and calibration requirements for the type of product manufactured in the site is performed according to the applicable standards.
This function provides QA oversight and support to manufacturing operation activities taking place in a high volume and fast-paced environment while ensure standardization of quality practices and identification and quick resolution of quality events and promote a prompt implementation of actions to prevent reoccurrences. This role provides leadership and managerial mentoring to Quality Operation, Calibration, Final Release and Biological and Sterilization Supervisors and Quality Engineers support metrology systems and the quality operation activities.
Collaborate with other internal and external quality, operation, supply chain 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
- Provide management and development to the Quality Supervisors and Quality Engineers directly supporting manufacturing and testing and measurement systems to ensure a proper right size structure and process is in place and maintained to ensure all Quality Control activities are completed on time and proper tools are in place for identification and resolution of product quality issues. If a nonconformity is detected will ensure proper containment measures are implemented and will work with other functional areas to provide appropriate product disposition based upon data generated, specifications and technical judgment.
- Lead the Biological Quality /Sterilization and Calibration teams ensuring activities required to maintain a suitable manufacturing environment (clean room) and calibration for all instrumentations used for the plant manufacturing, services and across multiple sites is conducted efficiently and in compliance to procedures and standards.
- Partner with Operations, Supply Chain, Maintenance, Engineering and other Quality Functions to assess overall product quality performance, including the identification of any product-specific quality and compliance risks and develops mitigation plans and actions to address them, based on a risk-based approach.
- Proactively drive continuous improvement activities to ensure problems are prevented and issued resolved efficiently and economically.
- Develop, maintain and monitor the quality control activities to record, analyze, track and trend quality data to improve the measurement systems, methods and processes while using statistical and technical knowledge.
- Serve as Quality Operation representative to evaluate and authorize product & process changes after assessing impact and working with impacted areas to prepare for the change.
- Develop, implement and monitor Key Performance Indicators (KPI) to Quality Operation performance around inspections cycle time, workload, response time over product quality issues and able to assess Cost of Quality (CoQ) for resolution for recurrent issues finding root cause and taking corrective action. Able to highlight trends, risks and opportunities for improvement.
- 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
- Recruit, train, lead and mentor direct reports
- Conducts GMP/GDP Training for plant employees to assure employee awareness of their responsibility to GMP compliance.
- Able to conduct internal audits and to act as the face and lead during regulatory and customer audits for the facility.
- Review and approve QMS documentation representing Quality Operation function, including but not limited parts specifications, test methods, Nonconforming Reports, CAPAs, Engineering Changes, Preventive Maintenance, Calibrations, Audit Reports, Work Instructions and Procedures.
- This position is required to work collaboratively with other function within the organization to identify and prioritize tasks required to achieve business goals associated to these projects.
Knowledge, Skills & Qualifications
- Ability to influence others at all levels within the organization using right leadership approach, proper negotiation skills and able to work in a team environment. Be a champion of quality throughout the organization.
- Acts with urgency and passion in a fast-paced environment. Enjoys helping others.
- Follows regulations, norms and procedures. Promptly responds to customer’s requests / Customer Focus.
- Data and trend analysis and reporting skills.
- Strong verbal oral and written communication skills for effectively interfacing with internal and external areas and global functions.
- The incumbent is expected to be proactive and 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
- Excellent 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.
- Excellent oral and written communication skills for effectively interfacing with internal and external areas and plants.
- Able to make decision, set priorities and complete projects and tasks with minimum supervision.
- Strong analytical, problem solving and decision-making skills.
- 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 be proactive and 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.
- 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 on parts drawing interpretation, Critical Quality Attributes (CQA) and the Quality Sciences (Statistical process Controls, Acceptance Sampling, Continous improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.)
- Experience writing, reviewing and/or approving quality documents.
Education And Experience
- Master is preferable but not required
- Bachelor’s degree in scientific or engineering degree required.
- Minimum of ten years of industry experience is required
- Five years of management experience
- Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred.
- Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook
Physical Requirements And Work Environment
- While performing the duties of this job, the employee is regularly required to talk or hear.
- This job operates mainly in a professional office environment and controlled manufacturing areas requiring special gowning.
- This job requires computer work for hours at a time, along with standing and walking.
- Typically requires travel 10-20% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Engineering
Primary Location
US-UT-Salt Lake City
Schedule
Full-time
Shift
Day Job
