Sr Quality Engineer-Design Assurance

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 64,000 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

Position Summary:

The Sr. Quality Engineer, Design Assurance provides quality support to Pharma development and analytical development projects to ensure compliance of developmental activities for safe and effective combinational pharmaceutical products and has familiarity to relevant regulations and USP, EP, FDA, ISO and ICH guidelines and relevant working experience is important for appropriate quality support. The Sr. Quality Engineer, Design Assurance works collaboratively with Pharma manufacturing sites and QC laboratories for stability and registration batches. and provides quality support for regulatory submissions and responses.

Responsibilities: Essential Duties

• Provides Design Assurance Quality Engineering support, to the R&D organization for new products, design modifications, and OEM customers; this includes creation of Quality and Validation plans, risk analysis, traceability matrixes, URS/FS, Design Reviews, customer interface, and follow through.
• Responsible for data trending and analysis, issue identification and resolution.
• Prepares reports for key quality metrics and lead continuous improvement efforts in Quality.
• Operates in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR, etc.).
• Defines implements and monitors metrics for key indicators. Prepare and present trend reports to management, as applicable.
• Drives continuous improvement efforts through facilitating, leading, and collaborating with cross function teams.
• Provides quality oversight for laboratory compliance including but not limited to equipment, instrument, chemicals, procedures, documentation, and quality investigations.
• Provides quality support to product and analytical development activities that are externally contracted to CRO, CMO or CL. Collaborates with GMP / GLP facilities to ensure quality compliance of related activities and associated documentation.

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 advanced knowledge of professional field and industry.
• Influences the development of and drives the application of principles, theories, concepts.
• Determines best 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.

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#MSL

$111,288 - $139,105

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required or equivalent combination of education and experience.
• 06-08 years related experience required.
• Regular and predictable attendance
• Occasional business travel required

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.

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, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

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

Environmental Conditions:

• Occasionally:Proximity to moving parts
• 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:Production/manufacturing environment, Lab environment
• Frequently:N/A
• Constantly:Office environment

Equal Opportunity Employer Veterans/Disabled

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

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