Quality Control Technician I

Indianapolis, IN

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Summary:

 The Quality Control Technician I will document permanent records for the company and its customers and will work with the Sr. Director of Quality to provide history of compliance for all customers and regulatory agencies.

Duties and Responsibilities:

Provide day to day manufacturing support, evaluate and address production concerns and problems through troubleshooting the design of components, tooling, fixtures, and equipment.

Implement productivity improvement projects resulting in improved manufacturing yields/efficiencies. Perform various test functions on devices/equipment and provide meaningful analysis/interpretation of data.

Product Analysis will be utilized to help determine solutions to quality and performance related problems. Must be literate in functional dimensioning and tolerance stack-up analysis.

Drives process/product enhancements through design for manufacturability/assembly reviews with product development engineering.

Identifies and communicates opportunities for improvement initiatives in daily work activities.

Collaborates with manufacturing and product engineering to implement new production processes, which meet engineering and quality specifications.

Assess process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements.

Evaluate and suggest alternative/improved methods for manufacturing processes.

Establish and support a work environment of continuous improvement that supports SonaCare Medical’s quality policy, quality system, and appropriate regulations for the area they support.

Additional duties requiring documentation include: maintaining quality records, clear understanding of enforcement of GMPs and 5S, following appropriate standard operating procedures, and having regular and sustained presence on the production floor.

Notifies management (production and quality) immediately when required to mitigate potential for product safety or quality issues.

Accurately and safely perform analytical test methods of related support activities as per procedures or protocols and reviews that results conform to standards.

Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.

Recognizes when a deviation from procedures or the quality system has occurred and initiates an investigation, as well as notifies superiors.

All other duties, as assigned.

Qualifications/Specifications:

Previous quality control or quality assurance experience, preferred.

Must be able to physically perform the functions of: stooping, kneeling, crouching, reaching, standing, walking, lifting, grasping, feeling, talking, and hearing.

Must possess visual ability to document company records and be familiar with SPEC sheets.

Must be able to lift 40 pounds.

Experience with SQF, GMPs, preferred.

Excellent attention to detail, required.

The ability to understand oral and written instructions in English, required.

The ability to work well in a team environment and have strong communication skills, required.

Excellent job performance and attendance records, required.

The ability to perform under pressure and communicate well with all departments, required.

Good computer skills, including Microsoft Office, required.

Analytical and problem-solving skills, required.

Good documentation practice (GDP) capabilities, required.

 

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