Intellectt Inc

Quality Assurance Specialist

Intellectt Inc Redondo Beach, CA
Intellectt Inc

Quality Assurance Specialist

Intellectt Inc Redondo Beach, CA
4 months ago
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Title : Quality Assurance Specialist

Location: Redondo Beach, CA, 90277

Duration: 12 Months

Duties And Responsibilities

  • Assess device related complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required. Review and approve complaint files.
  • Maintain eQMS system and all document control activities
  • Support external audits (e.g. customer, corporate, notified body)
  • Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, and supplier questionnaires
  • Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners
  • Support the execution of the site's training program
  • Maintain Quality records according to Exelint International policies and procedures
  • Support timely delivery of products to customers with lot release and preparation of certificates of analysis
  • Support external regulatory agency audits, providing
  • input to minimize potential for findings of non-compliance.

Job Description – Quality Assurance Specialist

  • Participate in post-market surveillance activities for licensed products.
  • Assist in fulfilling requirements under the EU MDR 2017/745 transition.
  • Maintain QMS procedures relatedto regulatory responsibilities, product licensing, andregulatory reporting.
  • Lead projects as needed by the qualitydepartment and participate in design control projects
  • Participate in internal audit program.
  • Otherprojects will be assigned as various business needs arise

Education

  • Bachelor’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent. Higher degree will be an advantage

Certifications

  • CQA,GMP certifications preferred

Key Attributes(experience, Skills And Technical Knowledge)

  • Minimum of 2 yearsregulatory or equivalent experience within a medical device organization
  • Documented trainingon current medicaldevice standards and regulations is an asset (e.g. MDSAP,EU MDR, ISO 13485, etc.)
  • Prior experience with eQMS(Qualio, Greenlight Guru, etc…)
  • Scientific knowledge, must be able to digestcomplex data while keeping the big picture throughgood analytical

Skills

  • Excellent writtenand Verbal communication skills with the ability to listen, articulate and advocate
  • Proactive, high performance, resultoriented and manageprojects with ethical integrity
  • Technical systemskills (e.g. MS office applications, databases, efficient online research)
  • Manage multipleprojects and deadlines
  • Ability to identify compliance risks and escalatewhen necessaryDemonstrate both creativeand critical thinkingskills

Thanks & regards,

Hima Bindu

IT Recruiter

Intellectt Inc

hima@intellectt.com, Contact No: 732-592-2008, Ext:454

517 Route 1 South, Suite 1115 Iselin, NJ 08830

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Staffing and Recruiting

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