SenDx Medical, Inc., a Radiometer Company, is an innovator in the medical electronics industry. At SenDx Medical, Inc. we develop, manufacture and market proprietary point-of-care blood analysis systems that provide measurement of critical diagnostic parameters for the health care market. We are currently seeking an experienced Quality Engineer for our expanding Quality Assurance Department.

In this position you will provide leadership, direction and have hands on involvement to ensure manufacturing processes conform to GMP, FDA and ISO standards. This position partners with Managers from Operations, Product Development, Marketing and Regulatory to drive improvements in the areas of product quality, reliability, operational efficiency, compliance, new product development/launches as well as continuous quality system improvements. You will provide oversight for regulatory compliance, manage the internal Audit Program, and facilitate external inspections. You will also be responsible for establishing and maintaining metrics to improve quality system processes.

This position requires exceptional communication, interpersonal and organizational skills. A strong understanding of the application of GMP, FDA and ISO standards is also required.

Job Responsibilities:

• Ensure adherence to Quality System requirements throughout product and process lifecycles. This includes products in design and development as well as products in production and the processes which support them.

• Analysis, trending and reporting of quality data in order to improve product and processes and make recommendations based on data analysis. 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 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.

• Verification of effectiveness of 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, 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 lean manufacturing concepts and tools in the performance of daily activities.

Education and Experience:

• Bachelor’s degree in an engineering or life science discipline
• Quality Certification preferred (CQE)
• Minimum 5 years experience in a regulated environment (medical device environment preferred)
• Experienced with validation and change control, design control, and risk management
• Experienced with failure investigations, reporting, and trend analysis
• Strong communication skills (both verbal and written)
• Experienced facilitating external inspections
• Experienced using lean manufacturing and problem solving techniques
• Experienced with quality regulations and standards (FDA, ISO, GMP)

SenDx Medical, Inc. offers an innovative and team-oriented work environment that produces quality products. Our benefits include:

**Medical, dental and vision insurance effective upon hire
**401k (including company match after one year service of 100% on the 1st 3% contributed, 50% on the 2nd 2% contributed, PLUS a 3% company retirement contribution after one year)
**Incentive bonus plan
**15 days Paid Time Off accrued annually
**10 paid holidays per year
**Tuition Assistance Program

LOCAL CANDIDATES ONLY — OUT OF AREA CANDIDATES WILL NOT BE CONSIDERED.

Equal Opportunity Employer

• Location: Carlsbad
• Compensation: Depends on Experience
• Principals only. Recruiters, please don’t contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.