Associate Director, Design Assurance

Company: B. Braun Medical Inc.
Location: Allentown
Posted on: June 13, 2021

Job Description:

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

• Lead, mentor, coach, and develop team of technical Quality Assurance professionals who collaborate with R&D on the design, development, and manufacturing transfer of new or changed medical devices, active medical devices and pharmaceutical products
• Ensure appropriateness application of company policies and procedures for pharmaceutical development / medical device design controls, risk management, test method development, statistical data analysis, and support of regulatory filings.
• Lead the continuous improvement of the quality system elements that support the design, development, and manufacturing transfer of new products.
• Maintain oversight of cGMP documentation, including, but not limited to pharmaceutical development reports, design history files, regulatory submissions, master batch records / device history records, change control, validations, methods, and technology transfer.
• Ensure documents are thorough, accurate and compliant to support regulatory inspections and submissions.
• Provide support for investigations and recommend, develop and implement effective corrective actions.
• Provides support during regulatory inspections and customer audits.
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
• Proactively investigates, identifies and implements improved quality practices.
• Ensure operations within approved department budget.
• Responsible for personnel actions including hiring, performance management, and termination.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. 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 breadth of professional field and industry knowledge.
• Ability to integrate critical information and champion advanced strategies/concepts through the organization.
• Drives development of advanced technologies, principles and processes.
• Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.
• Ensures budgets, schedules, and performance requirements are met.
• Judgement is required in resolving complex problems based on experience.
• 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, Master's degree preferred.
• 10-12 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance

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.

Other

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:N/A
• Frequently:N/A
• Constantly:N/A

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Noise Intensity:Moderate
• Occasionally:Other
• Frequently:N/A
• Constantly:Office environment

Notices

Equal Opportunity Employer Veterans/Disabled

Keywords: B. Braun Medical Inc., Allentown , Associate Director, Design Assurance, Other , Allentown, Pennsylvania