Calibration and Maintenance Specialist
2 weeks ago
Job Overview
The Calibration and Maintenance Specialist plays a crucial role in overseeing the Calibration and Preventive Maintenance (PM) program as directed by the Senior Manager of Quality Systems. This position is essential for ensuring the effectiveness and compliance of the MDS FLKS Calibration and PM initiatives.
About Us
At BD, we are dedicated to advancing healthcare globally. Our mission is to transform health through innovative solutions, and we rely on the creativity and dedication of our diverse teams to achieve this goal. Join us in an environment that fosters growth, learning, and personal development.
Key Responsibilities:
- Serve as the primary coordinator for the Calibration and PM Program at the designated site.
- Advise asset owners on calibration requirements and assist in defining calibration parameters such as usage range, frequency, and tolerance.
- Guide asset owners in identifying preventative maintenance needs and establishing relevant PM parameters.
- Maintain accurate records of all assets within the Blue Mountain Regulatory Asset Manager (BMRAM) database.
- Ensure timely calibration and maintenance of all assets in accordance with established schedules.
- Support asset owners in documenting and addressing out-of-tolerance issues with appropriate corrective actions.
- Authorize calibration/PM extensions and out-of-tolerance situations.
- Document justifications for equipment that does not require calibration.
- Provide necessary calibration and PM labels to asset owners.
- Ensure compliance of calibration and PM systems with corporate standards and applicable regulations.
- Maintain compliance with record retention requirements for calibration and PM documentation.
- Oversee the approval and management of external calibration service providers in line with supplier management protocols.
Qualifications:
- Bachelor's Degree in Engineering or a related field.
- A minimum of 2 years of relevant experience in the industry.
- Familiarity with US and International regulations and standards applicable to the medical device sector (FDA QSR, ISO13485, EU MDD/MDR).
- Experience with SAP systems.
Why Work with Us?
Joining BD means becoming part of a team that values your insights and contributions. We encourage you to bring your authentic self to work and support each other in achieving excellence. We are committed to doing what is right, holding each other accountable, and continuously improving.
At BD, you will find a culture that promotes learning, growth, and the opportunity to make a meaningful impact in the world of health.
Equal Opportunity Employer
BD is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility, veteran status, or any other protected status.
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