Quality Engineering Supervisor

Quality Engineering Supervisor

In this exciting role as a Quality Engineer Supervisor you will have responsibility for leading teams through Quality System Transformation by defining and trending metrics. This role will lead multiple projects within a larger program with a focus on creating more usable and simpler to follow processes, reducing burden within our quality systems and driving efficiency.

Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to drive improvements to Key Performance Indicators. Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements. Support the maintenance and development of the Corrective And Preventative Action (CAPA) and internal Non-Conformance system to support the overall facility quality management system. People supervision and process management of elements under your responsibility.

Ensures the quality assurance programs and policies are maintained and modified regularly. Ensure products adhere to company and industry quality standards Drive proactive Quality improvements in partnership with all related business functions. Formulate strategic plans to increase productivity in the business Works within an operations team to identify and implement effective controls to support the development, qualification, and distribution of products to meet or exceed internal and external requirements Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System. Perform statistical analysis to determine process capability and to analyze trends Maintains schedules for projects; identifies problems and recommends solutions to all project activities. Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as ship holds, service errors, line yields, final release, supplier performance and customer experiences to internal product improvement teams Acts as an effective leader and team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Support audits, CAPA / NC / MRB investigations and reports Management of quality process within the facility and supervision of personnel Previous experience overseeing a team, quality supervisor experience is preferred People management skills, conflict resolution and results oriented. Perform other related duties as assigned

To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor's Degree with 5+ years of work experience in Quality and / or experience in a regulated industry OR Advanced Degree with 3+ of work experience in Quality and / or experience in a regulated Knowledge of Quality Systems Requirements (ISO 13485, CFR 820 & LATAM) Knowledgeable of Board of Pharmacy and NABP requirements Experience and knowledge working with product holds, nonconforming products, and recalls Experience and knowledge working with NC's (nonconfromances) and CAPA's Internal / External QMS Audit experience Green Belt / Black Belt Certificate (or experience) preferred Process Development Experience Project Management Experience Quality Agreements Schedule management Experience with SAP / Blue Yonder, and eQMS systems, like Veeva Vault, Agile, Mastercontrol applications (desirable) Ability to become NABP Designated Representative

Lead Has a Sense of Purpose & Inspires others Has a desire & ability to "step up" Takes accountability Demonstrates critical judgement

Engage Communicates with Impact Builds and sustains relationships Plans and Organizes Is present & available

Develop Develops Leaders Builds High Performance people & teams Invest in personal growth Develops Organization capability

Improve Creates value for the customer Demonstrates Continuous Improvement via results. Creates a culture of inclusion & involvement Makes the tough calls when organizations are not performing

Demonstrates Functional Mastery Adept at relationship building across functions and geography to effectively work with and leverage centers of excellence. Excellent computer skills (MS Word, Excel, and PowerPoint) Detail oriented and strong data driven analytical approach to HR processes Effective with combining Business and HR Acumen to build organizational capability Able to support employees on multiple shifts; ability to be flexible with scheduling outside of normal office hours. Core hours are 8 to 5 but on occasion supporting an off shift maybe required. Ability to communicate positively and professionally with employees at all levels of the organization Resourceful and well organized. High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities.