Quality Assurance Associate

BRIDGEMED SOLUTIONS INC

Quality Assurance Associate

Irvine, CA
Full Time
Paid
  • Responsibilities

    Benefits:

    401(k)

    401(k) matching

    Competitive salary

    Dental insurance

    Free food & snacks

    Health insurance

    Paid time off

    Vision insurance

    BridgeMed Solutions, Inc is seeking an Data Entry Specialist. Training will be provided.

    Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization this is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives.

    Job Title: Quality Assurance Associate

    Experience: We are actively seeking candidates with production experience or a comparable background.

    Location: Irvine - Local candidates only (must live in Orange County)

    Job Type: Full-time

    Pay: Starts at $18-$26 per hour DOE

    Benefits: PTO, Sick days, Holiday Pay, Vision-Dental-Health Coverage

    RESPONSIBILITIES

    Laboratory Environment: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job safely. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

    JOB REQUIREMENTS

    Required Education:

    High school diploma (or equivalent), or higher education

    Bachelors Degree is a plus (Biomedical, Mechanical, Life Science, Public Health or Biology)

    English proficiency

    Required Skills:

    Support departmental operations by assisting customers with document revisions and internal/external document requests.

    Collaborate cross-functionally to ensure timely and effective execution of document review activities.

    Proficiency with the ComplianceWire electronic training system, including tasks such as assigning curricula, generating training reports, and creating or revising curricula. Issue and reconcile equipment logbooks, laboratory notebooks, and controlled documents (e.g., SOPs, forms, and logs).

    Maintain and organize documents within the QA archive; retrieve archived documents upon request.

    Uphold GMP standards and QA policies, including adherence to Good Documentation Practices (GDP).

    Assist in maintaining inspection readiness and provide support during regulatory and other audits.

    Perform additional duties as assigned by Quality Management.

    Physical Requirements

    Able to sit or stand for up to 2 hours at a time.

    Able to lift and carry up to 25 lbs.