What are the responsibilities and job description for the Quality Specialist, Akura Medical position at Shifamed?
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 responsible for key quality elements, including CAPAs, product distribution, complaints, training, calibration, and preventive maintenance, supplier management, internal and external audit schedules, document control and other duties as assigned.
Responsibilities, Skills & Hands-On Experience
- Lead development of quality management system, including but not limited to, quality inspections, CAPA, audits processes, as needed.
- Author memos, reports, protocols, CAPAs & other appropriate documentation as required.
- Maintain various quality system elements as needed, including but not limited to, audit schedules, Calibration/Preventive Maintenance schedules, CAPA logs, external standards, and supplier files.
- Drive the development of all digital quality management system elements.
- 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.
- Review engineering drawings for completeness including notes, packaging requirements, and inspection requirements.
- Qualify and maintain the suppliers per the supplier management process as needed.
- Develop and maintain document control and training systems and ensure compliance.
- 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 in a quality role
- 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.
- ASQ certifications are desired.
- 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.
Salary : $75,200 - $95,200
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