Fellow Quality System Engineer

Recruiter: Spencer Gregory Hale     Fellow Quality Systems Engineer      About the role:  Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provide quality engineering support within technical development concepts, new product development, operational, or system/services support.  Collaborates with Quality management to recommend, design and implement functional process improvements.  May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.    ***This is a defined-term position***   Your responsibilities include:

Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation. Champion departmental or cross-functional engineering initiatives. Provide project direction, coaching, and mentoring for engineering and technical team personnel. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements. Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Act as leader or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues. Advise management on potential improvements or enhancement to quality systems and processes in the company. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable: Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Bachelor’s degree in Engineering, Science, Quality, Regulatory, or a related technical discipline. Minimum of 10 years of quality systems, quality engineering, manufacturing quality, or regulated industry experience, preferably within the medical device industry. In-depth knowledge of global quality system regulations and standards, including FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable regional regulatory requirements. Demonstrated experience leading or stewarding global quality system processes, procedures, policies, or communities of practice across a matrixed organization. Experience developing, maintaining, and improving quality assurance programs, process controls, procedures, metrics, and governance models that support compliance and continuous improvement. Proven ability to serve as a subject matter expert for quality system requirements, including interpretation of regulations and implementation of new or revised requirements. Experience supporting internal and external audits, including audit preparation, audit-facing subject matter expertise, response strategy, and corrective action support. Demonstrated ability to lead