Quality Manager I - Medical Devices |
| Jun. 01, 2009 - Aug. 01, 2009 |
| Location: | Salt Lake City, UT |
| Salary Range: | DOE |
| Exempt/Non-Exempt: | Exempt |
| Benefits: | healthcare, vacation, 401k match, merit bonus |
| Employment Type: | Full Time |
| Employer: | Boston Scientific |
| Description: | To develop, establish and maintain quality systems, engineering methodologies, and practices which meet BSC, customer, and regulatory requirements. To serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives supporting departmental, functional, site, divisional and corporate quality goals and priorities. To provide focused quality engineering support within new product development, operational, and system/services
This position will be primarily responsible for the management and execution of Supplier Quality Engineering, QC testing (incoming, in-process, environmental, and final product), final product release, and the calibration program. |
| Duties: | Demonstrate a primary commitment to patient safety, product quality and compliance with the BSC Quality Manual and its governing regulations.
Provide a leadership role in championing departmental or cross-functional vendor quality initiatives.
Provide project direction, coaching, and mentoring for technical team personnel.
Investigate, identify, and implement best-in-class Quality Engineering practices.
Provide technical guidance mentoring for identifying and resolving quality issues.
Identify and implement effective processes and systems to support QC and Supplier Quality.
Project management and leadership in the implementation of new requirements (regulatory, corporate and local) for the quality systems managed.
Act as an effective leader/team member in supporting quality disciplines, decisions, and practices.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Develop and execute streamlined business systems which effectively identify and resolve quality issues.
Conduct qualification, verification, and validation activities.
Release product for distribution.
Participate in external Quality System audits
Conduct activities, tasks, and documentation per quality system requirements.
Supervise Quality inspections and auditing.
Provides performance metrics and monitoring for areas managed
Evaluate non-conformances and implement appropriate corrective actions.
Coordinate calibration and environmental monitoring activities of Quality System.
Conduct work in and maintain a clean, safe, health conscious work area. .
Conduct other tasks and responsibilities, as requested |
| Qualifications: | Qualifications
5 - 8 years experience in Quality Engineering or related discipline. 5-8 years medical device experience required. Strong written/verbal communication skills. Demonstrated use of Quality tools/methodologies. Project management skills. Certified Quality Auditor; ASQ or ISO 13485. Previous supervision experience preferred. Technical degree (BS) engineering preferred.
Required Skill and Competencies
Ability to work well with others in a team setting.
Ability to conduct statistical, geometric, and mathematical calculations.
Ability to conduct responsibilities substantially free from routine supervision.
Ability to read and understand engineering drawings.
Ability to develop inspection methods and metrology requirements
Ability to successfully manage projects
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