11 days old

QA Compliance Specialist I

BBraun Daytona Beach
Daytona Beach, FL 32117
  • Job Code
    126119744

Overview

About B. Braun

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.



Responsibilities

Position Summary:

Responsibilities: Essential Duties

  • Participate in the development and directions of company's Quality Compliance System to ensure manufacture of products that meet the necessary quality standrads ensuring the quality system'scontinued compliance with all applicable regulatory requirements.
  • Oversee the company risk management program (Annual Reports); provide risk assessment on product nonconformance and field performance issues. Support the company audit program (internal, suppler, customer, and regulatory) to ensure timely and effective corrections to maintain compliance with FDA cGMPs and Quality System Regulations and ISO standards.
  • Support the company supplier management program (ASL, Supplier Quality Agreements) to ensure accurate and compliant supplier file content.
  • Support the company cGMP knowledge management program with HR and Training Department to ensure cGMP proficiency and competency for each worker category. Interface with Manufacturing, Regulatory Affairs, Research & Development, Engineering and other technical disciplines to represent Compliance in project teams, with the objective to assure that project quality compliance objectives are met.
  • Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance for projects and/or strategic activities. Provide / formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues.
  • Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures. Development, implementation and establish dashboards, accountability boards and metrics to measure quality function performance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Additional responsibilities and experience:
  • oversight of audit hosting/response
  • complaint management
  • quality system compliance
  • CAPA trending and oversight
General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

Expertise: Knowledge & Skills

  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving all day-to-day problems.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.




Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

  • Bachelor's degree required or equivalent combination of education and experience.
  • 04-06 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable attendance
  • Ability to work non-standard schedule as needed

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



PI126119744
Posted: 2020-11-17 Expires: 2020-12-18

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QA Compliance Specialist I

BBraun Daytona Beach
Daytona Beach, FL 32117

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