Danaher Corporation Quality Assurance Supervisor in Orange, California
Danaher Company Description
KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments
Performs all duties in compliance with FDA, ISO, EPA, OSHA and other regulatory requirements. Coordinates Quality process improvements. Works with R&D (sustainment) for legacy products and product transfer to ensure test methods and process capabilities for products meet design requirements. The ideal candidate will be a charismatic leader with ability to create followership and influence business level decision making. He/She must have strong organizational skills and ability to keep track of and manage multiple projects and priorities, creative and innovative in coming up with solutions to complex problems and possess a strong level of integrity and personal accountability; able to instill same in team. Other duties may be assigned in addition to those listed below:
Essential Duties and Responsibilities:
* Oversee the calibration system.
* Drive continuous improvement initiatives through direct reports and by participating in cross-functional continuous improvement initiatives.
* Manage the Material Review Board (MRB) by dispositioning nonconforming materials, investigating root cause, and identifying/ implementing corrective actions in compliance with applicable regulatory requirements.
* Perform detailed investigations of non-conforming product and customer inquiries, determine root causes and monitor the effectiveness of implemented corrective actions.
* Oversee and ensure timely completion of all quality control testing, including special project/protocol testing.
* Assist in implementing quality and regulatory requirements (e.g., FDA, QSR, cGMP), and ensure compliance with testing SOPs and specifications.
* Perform and monitor the testing techniques and accuracy of all related records and documentation.
* Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
* Maintain expenses at or below budget.
* Ensure employees are properly trained and prepare/support internal and external audits. * Implement process and testing improvements. * Own/support CAPA projects. * Lead and develop team. Train team in use of all related processes and documentation. Develop measurement and analysis criteria to ensure product conformity and Quality Management System effectiveness. * Make appropriate staffing recommendations. * Solve problems. * Evaluate performance via performance appraisals and ensure employees have clear performance objectives and development plans. * Prepare, review and revise, as required, SOPs and specifications. * Write memos, reports, protocols, Capital Acquisition Requests and other appropriate documentation. * Assure equipment maintenance and calibration, and internal audits are performed on schedule. * Performs other related duties as requested or assigned. * Key Performance Measurements: * Internal non-conformances * External non-conformances * Quality improvement * Labor productivity * Certification in applicable DBS tools * Compliance
Qualifications: * Must have a High School diploma * 2-3 years of supervisory experience Preferred: * Preference will be given to those who have worked in the Class II or higher medical device industry * Chemistry, or Raw Materials testing and Method Validation. * Experience in 21 CFR 820, ISO 13485 * Design Control knowledge and Validation process knowledge * Excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers * Experience managing the MRB (Material Review Board)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Abilities: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please no faxes or phone calls. Only considered candidates will be contacted. Thank you for your interest in Kerr Corporation!
Kerr Corporation is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: KaVo Kerr
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Orange
Req ID: KAV002507