QA Operations Manager

ICU Medical Salt Lake City , UT 84101

Posted 2 weeks ago

Job Title

QA Operations Manager

FLSA Status


Position Summary

Responsible for direction, coordination and managing quality operation activities at the Salt Lake City Facility, from the raw material reception to the final release of products, ensuring that all processes involved in the manufacturing of molded, sub assembled and finished medical devices are met and performed in an environment of compliance to applicable procedures, industry standards and regulations.

This function oversees and lead the QA Operation team that support the manufacturing of a high volume of molded components, assemble of components in high speed assembly equipments, and manual assemblies and work on standardizing quality practices and provide quick resolution of quality events promoting the implementation of actions to prevent reoccurrences.

Collaborate with other quality and operation functions to lead and support initiatives in QMS Harmonization, Microbiology, Environmental Monitoring, Calibration, Validation, Audits, Nonconforming Material, CAPA, GMP, GDP and Product performance monitoring,

Essential Duties & Responsibilities
1.Provide leadership to the QA Supervisors to ensure a proper right size structure and process is maintained to conduct the statistical based product quality monitoring of the manufacturing processes and that proper tools are in place for recognition and resolution of 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.
2.Develop, maintain and monitor the quality operation activities to record, analyze, track and trend quality data to improve the measurement systems, methods and processes while using statistical and technical knowledge.
3.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.
4.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.
5.Recruit, train, lead and mentor direct reports
6.Review and approve documentation, including but not limited to Quality Operation Test Methods, Procedures, forms, Master Batch Record Activities, Validations Protocols and reports.
7.Assist with Customer, FDA and other regulatory agency inspections as needed.
8.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.
9.Conducts GMP Training for plant employees to assure employee awareness of their responsibility to GMP compliance.
10. 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 with leadership, proper negotiation skills and work and in a team environment.

  • Acts with urgency and passion in a fast-paced environment. Enjoys helping others.

  • Interdisciplinary Skills, Analytical Skills, Presentation Skills, result oriented.

  • Excellent organizational and time management skills with a high level of attention to detail.

  • 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.

  • Excellent 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.

Education and Experience

  • Bachelor's degree in sciences or technical area

  • 8-10 years of experience is required; or equivalent combination of education and experience.

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

  • Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook

Minimum Qualifications

  • Must pass pre-employment drug screen and background check

Travel Requirements

  • Typically requires travel 10-20% of the time

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.

We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.

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QA Operations Manager

ICU Medical