1 Quality Specialist, Akura Medical Job in Campbell, CA

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Quality Specialist, Akura Medical

Shifamed LLC

Campbell, CA | Full Time

$90k-109k (estimate)

8 Months Ago

Quality Specialist, Akura Medical

Shifamed LLC Campbell, CA

$90k-109k (estimate)

Full Time 8 Months Ago

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Shifamed LLC is Hiring a Quality Specialist, Akura Medical Near Campbell, CA

Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. To learn more about Akura Medical, please visit www.akuramed.com.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

As the key member of quality team, you will be taking a variety of quality responsibilities, including document control, training, calibration, and preventive maintenance, CAPA logs, internal and external audit schedules, and other duties as assigned.

Responsibilities, Skills & Hands-On Experience

Develop and maintain document control and training systems and ensure compliance.
Drive the development of all digital quality management system elements.
Lead development of quality management system as needed, including but not limited to, quality inspections, CAPA, audits processes, as needed.
Maintain various quality system elements as needed, including but not limited to, audit schedules, Cal/PM schedules, CAPA logs, external standards, and supplier files.
Develop Device History Record structure and perform review of DHR records, as needed.
Ensure all quality records are stored and retained per procedures.
Prepare, review and revise, as required, SOPs and specifications, and ensure compliance with SOPs.
Write memos, reports, protocols, CAPAs & other appropriate documentation as required.
Review engineering drawings for completeness including notes, packaging requirements, and inspection requirements.
Qualify and maintain the suppliers per the supplier management process as needed.
May perform other duties as assigned.

Education & Work Experience

AS/AA degree required, BA/BS degree preferred.
Minimum give (5) years of experience in medical device industry.
Experience in reading parts drawings, understanding dimensioning and inspections.
Works independently to achieve department goals and objectives.
Excellent communication skills: ability to work both independently and in project team setting.
Must be computer literate.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $80,000 to $95,000 equity benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.