2 Quality Systems Specialist II Jobs in Bothell, WA
BRUKER is Hiring a Quality Systems Specialist II Near Bothell, WA
Responsibilities Responsibilities
- Oversee the Change Management processes and serve as an subject matter expert (SME) on document change processes. Chair Change Control Board (CCB) meetings, identify and implement improvements to the change process, track and report system performance, and usher changes to completion and implementation.
- Manage training for the NanoString system including:
- Collaborate with functional area leaders to identify training needs for all departments
- Assign training when new procedures are implemented
- Train and support people managers in monitoring training compliance
- Track training compliance and identify and implement improvements
- Develop and implement training and training tools for the Quality System to be used by all employees.
- Manage the monitoring and distribution of national and international standards that are applicable to our business.
- Monitor for updates to existing standards
- In collaboration with Regulatory, ensure completion of gap assessments when standards change.
- Work with Regulatory on identifying and implementing new standards
- Acquire requested standards and deliver to requestor
- Support the eQMS electronic documentation system, as needed
- Participate in ISO inspections and customer audits as a remote contributor
- Perform other relevant duties as may be assigned by management.
- Maintain frequent and regular communication with Manager on current activities, including priorities, progress, completions, and roadblocks.
- Analytical decision-making skills to apply logical or scientific thinking principles to a wide range of intellectual and practical problems.
- Good knowledge and skills in using advanced personal computer productivity programs for word processing, spreadsheets, database manipulations, and flow charts.
- Demonstrates working knowledge of ISO 9001 quality system standard.
- Good written and verbal communication with all levels of the organization, management, customers, and suppliers.
- Experience in the medical device, diagnostic, or the biotechnology industries is a plus
Minimum Experience : 3-5 years quality-related experience in the biotech, pharmaceutical, and/or device industries.
At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $$62,000 and $85,000 provides an opportunity to progress as you grow and develop within a role.The base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.
Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Certain positions at Bruker require compliance with export control laws and as a result, all interviewed candidates for all positions will be screened pre-interview to determine their eligibility in light of export control restrictions.
Job Summary
Full Time
Durable Manufacturing
$87k-108k (estimate)
07/03/2024
07/31/2024
bruker.com
CARTERET, NJ
3,000 - 7,500
1960
Public
JEFF PARRELL
$1B - $3B
Durable Manufacturing
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About BRUKER
Bruker is a manufacturer of scientific instruments for molecular and materials research and industrial analysis.
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