Senior Applications Architect, Quality Job in Brea 92821, California US
Job Description
This position will be responsible for providing leadership in supporting Quality and Regulatory Affairs organization stakeholders in the IT implementation and support of the company’s Quality Management System (QMS). This will include functional support of a new worldwide Complaint and CAPA management system utilizing the Master Control QMS product. The successful candidate will play a key role as a member of the core implementation team, understanding the current FDA-validated environment and working within the team toward a successful transition to the new system. The company will leverage the capabilities of the Master Control system, in the workflow and design phase of its implementation, to improve business processes and eliminate redundant legacy systems. This position is a good fit for someone interested in building a reputation as the expert “go to” person for any technical aspect of Beckman Coulter’s QMS. The position will require technical ability to design and implement Master Control user interface through the products HTML based web form design tool.
In addition to the initial implementation of Complaint and CAPA within Master Control, the position will provide support of other areas of functionality within the Quality Management System such as Training Record Management and Engineering Processes. This will include deployment of areas of the Oracle EBS as it relates to QMS.
The role includes the following major activities:
• Analyses of functional specs and translation into system technical requirements.
• Design of Master Control forms through HTML
• Definition of system interface requirements between QMS IT components
• Development of integrated test plans and procedures for system changes
• Coordination of projects to address user needs within the framework of the global IT system design
• IT support of worldwide QMS deployment, including systems configuration, system usability and system performance.
• On-going support of installed systems to facilitate scalability and adaptability of deployed solutions.
Specific requirements:
1. Minimum three years of experience supporting a small to mid size IT environment, preferably in an FDA regulated industry.
2. Minimum three years in system interface design using HTML or similar web tools.
3. Broad knowledge of the Quality Management function and how IT systems are used to optimize processes.
4. Solid working knowledge of QMS or similar IT systems. Familiarity with Master Control product is preferred.
5. Excellent oral and written communication skills.
6. Excellent analytical skills, ferreting out root cause of a problem in conditions of ambiguity, and then acting to resolve constructively.
7. Calm, self-possessed demeanor, able to handle potentially stressful or deadline-driven situations constructively.
8. Experience in a leadership role of a small to medium-size process improvement or systems implementation project would demonstrate your fitness for the project related portion of the job.
9. Preference given to candidates who have a Bachelor’s Degree in Management Information Systems.
10. Work well independently, self-motivated and directed.
Education:
Bachelor’s degree in field with 5+ years experience OR
Master’s degree in field with 3+ years experience OR
Doctoral degree in field with 0-2 years experience
Apply online at: https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetailccid=bupJEdUjsTs=job_REQUISITION_NUMBER=96613
Company description:
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Beckman Coulter is an operating company of Danaher Corporation. Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.