Senior Quality Analyst, Quality Systems - United States
Are you looking for a challenge within a dynamic global organisation or a German family business? At B. Braun you can find both. For more than 175 years and counting, B. Braun is amongst the world's top healthcare companies operating in 64 countries, with over 55,000 experts networking their knowledge every day. You can thrive in this strong culture of continuous exchange. Become a part of the B. Braun family and share your expertise. Together we improve healthcare.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.
- Position Summary:
- The Senior Quality Analyst leads activities related to continuous system improvement of Quality Systems. Position must possess and apply a broad knowledge of Quality principles, practices, and procedures to drive system improvements. Position will work with business owners to solve documentation problems and provide a resource of knowledge of the QA Quality Systems to the company. Position will work with system users to provide analysis and quality trend information, solve issues, provide training/ mentoring and drive improvements. Assists in the maintenance of company policies and procedures to ensure compliance with regulatory requirements.
- Responsibilities: Essential Duties
- Champion and lead on Quality continuous improvement projects.
- Responsible to implement and integrate Corporate Harmonized Quality System COPs into the Irvine site.
- Perform data analysis, quality trending, reporting for BBMI Irvine Quality Systems, such as Quality System Management Reviews (QSMR), discrepancy, product complaint, and CAPA investigation and corrective action systems, SAP Quality Module (QM), document management system, training management system, Internal and External Audit management, recall management, calibration and preventive maintenance management systems and change control management systems.
- Perform and support quality investigations in a timely and thorough manner per applicable investigation procedures.
- Prepare and analyze data required for Quality System Management Reviews (QSMR). Provides various Quality System performance indicators to senior management.
- Facilitate and coordinate annual Quality Product Profile review and reporting.
- Provide QA oversight for electronic quality control record systems such as SAP QM, MES/EBR, LIMS, etc.
- QA Approver role in B.DoCS for Quality System procedures.
- Facilitate training on SOP updates relating to changes in Quality System processes along with various special interest training to the organization as needed.Assist and cooperate during FDA inspections and internal audits providing various Quality System data requests along with support room participation as needed.
- Ensure overall compliance to all Quality System SOPs and associated processes.
- Expertise: Knowledge & Skills
- Strong working knowledge of investigation and corrective action systems (CAPA and DSMS), change control management, validation, and process controls
- Strong understanding of Quality Systems
- General knowledge of product usage, medical terminology, and environmental regulations
- SAP knowledge and experience
- Must be able to work with all functional groups
- Demonstrated customer relations skills.
- Ability to act effectively as a team member and resolve problems.
- Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages.
- Detail oriented and able to provide accurate output. Strict attention to detail required. Problem detection ability a must.
- Ability to understand and implement written and verbal instructions.
- Ability to organize and prioritize work and meet deadlines
- Ability to exercise initiative and work independently
- Expertise: Qualifications - Experience/Training/Education/Etc
- Bachelor Degree in an applicable field (i.e. Science, Engineering) or an equivalent combination of education and experience
- Minimum 5 or more years of experience in Quality Assurance or Quality Systems in FDA regulated industries, preferably pharmaceutical and medical devices.
- Experience in auditing for performing and hosting audits, supplier audits, or FDA regulatory inspections
- Advanced degree or certifications
- Quality Systems training/seminars
- Knowledge of basic statistical analysis
- Thorough knowledge of company products and processes
- 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.
- 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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
- Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
What we offer
Other duties as assigned.
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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. The noise level in the work environment is usually moderate.