9 days old

Quality Engineer

Danaher
Carlsbad, CA 92008

The primary responsibility of this position is to identify, monitor and improve quality metrics and processes in support of the quality goals of SenDx Medical, Inc. This position actively participates in team activities to ensure that the manufacturing processes are compliant with company procedures as well as FDA/ISO regulations and standards. The incumbent will serve as a technical resource to product development, manufacturing and suppliers to improve process capability, reliability and the quality of products. Will create quality and process improvement plans and drive root cause analysis activities.

PRINCIPAL ACCOUNTABILITIES/ESSENTIAL JOB FUNCTIONS - Ensure adherence to Quality System requirements in an FDA and ISO regulated environment throughout product and process lifecycles. This includes products in design and development as well as products in production and the processes which support them.
- Perform investigations and root-cause analysis activities as they related to Corrective/Preventative Actions (CAPA), and drive continuous improvement.
- Perform analysis, trending and reporting of inspection and test data to insure conformance to specifications.
- Perform design and process validation studies in conjunction with R&D, Engineering and Manufacturing to ensure compliance to applicable standards.  Ensure validation and revalidation of production cells by evaluating equipment and processes for critical and non-critical parameters, performing capability studies and integrating findings into validation protocols.
- Ensure compliance in manufacturing areas and escalate nonconforming situations. Initiate and lead root cause investigations and documentation for non-conformities. Review dispositions of non-conformities for compliance and presence of objective evidence.
- Perform in-house failure and complaint investigations to determine deficiencies in product design and manufacturing processes.
- Perform and/or assist with conducting verification of effectiveness checks related to corrective and preventative actions as identified in the SenDx corrective and preventative action program (CAPA).
- Identify, initiate and lead process and compliance improvement. Implement improvements and methods for measuring effectiveness of changes.
- Administration of statistical sampling plans for incoming inspection and finished product testing.
- In conjunction with engineering and manufacturing, assist with the implementation and maintenance of statistical process controls were applicable.
- Assess and ensure compliance with applicable standards of design control, risk management, adequacy of testing and process and production control systems.
- Compilation and analysis of information for Quality Management Reviews and external audits.  Perform trending on key Quality System metrics.
- Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.
- Perform other duties & projects as assigned.
 
Education: BS or BA in Engineering or Life Sciences
Experience: Minimum of 3 years of Quality Engineering experience in an FDA regulated Enviornment (Medical products, Pharma or Biotechnology).
Skill/Aptitude: Familiarity with QSR (FDA) & ISO Standards, Design and Process Validation Experience
Alternate Qualifications: ASQ QE Certification desirable
Required Licenses: None

Reports To: Manager, Quality Assurance
Supervisory Responsibilities: None, may be required to supervise technician or inspector on a project basis.
Key Internal Customers: Daily interface with Research and Development, Engineering, Quality Control, Regulatory Affairs, Manufacturing, Manufacturing Engineering, Technical Service on project and product issues. 
Key External Customers: Occasional interfacing with Radiometer and/or distributors for purposes of resolving product problems.

Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page€”Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
 

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Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Medical Device

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Posted: 2020-05-21 Expires: 2020-06-20

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Quality Engineer

Danaher
Carlsbad, CA 92008

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