Design Assurance Manager, IS

Join Nextern’s growing engineering team as a Design Assurance Manager and play a key role in guiding the quality and reliability of innovative medical technologies. In this role, you will mentor and lead Design Assurance and Test Engineers while helping shape the strategic direction of requirements management, verification, and quality system processes. Working cross-functionally with engineering, quality, and manufacturing teams, you will support product development programs from concept through commercialization. If you enjoy solving complex technical challenges while building strong teams and processes, this is an exciting opportunity to make a meaningful impact.

DUTIES AND RESPONSIBILITIES:

• · Responsible for the individual contribution, supervision, and development of their team
• · Define and communicate objectives for the department linked to organizational goals/vision
• · Lead employees in driving continuous improvement in department owned processes
• · Provide routine communications with cross functional peers to assure awareness
• · Provide timely performance & developmental evaluations of department staff
• · Direct project assignments for engineers & technicians.
• · Prospectively identify resource needs; recruit, interview, hire, and onboard candidates
• · Work cross functionally in identifying and resolving technical issues
• · Build strategic partnerships with internal and external stakeholders
• · Demonstrates effective change leadership.
• · Review, analyze, and present Quality System metrics to senior staff
• · Communicate quality policies, strategies, and procedures to the organization
• · Own, collaborate, and drive changes to QMS based on monitored performance and regulatory landscape
• · Identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc…
• · Identify and drive opportunities for risk reduction, cost improvement, and budgetary responsibility
• · Adheres to all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

SUPERVISORY RESPONSIBILITIES:

• · Directly supervises employees within the quality department(s)
• · Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
• · Interview, hire, train, and support employees; assign and direct work aligned with competency
• · Ensure adequate resources to complete Quality objectives and maintain regulatory compliance
• · Assess, develop, and appraise employee capability and performance to assure effective support

Requirements

• Minimum Education:
• o Bachelor’s in Life Science discipline or equivalent combination of education and experience.
• · Minimum Experience:
• o 5+ years of experience in a quality role within a medical device development environment
• o 3+ years of experience in a people or technical leadership role
• o Demonstration of strong technical writing skills in all job responsibilities
• · Strong leadership skills to motivate and enable department employees to meet objectives
• · Ability to work in a highly matrixed and geographically diverse business environment.
• · Adaptability to work effectively within a team in a fast-paced, changing environment.
• · Strong organizational, planning, and follow-up skills to ensure accountability
• · Demonstrated capability for effective collaboration and alignment across departments
• · Strong written and verbal communication skills to effectively communicate at all levels in the organization
• · Experience working in a broader enterprise/cross division business unit model preferred
• · Ability to set goals and provide constructive feedback to enhance relationships and improve business results
• · Aptitude for Change Leadership, working effectively within a team in a fast-paced environment
• · Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook)
• · Specialized Knowledge:
• o Direct experience in Quality functions for medical device product development, manufacturing, post-market surveillance, and QMS monitoring
• o Direct experience with medical device capital equipment and/or systems, including, but not limited to: requirements management, software qualification, regression analysis, V&V, DFM, and electrical safety standards (e.g. IEC 60601-1)
• o Proficiency in reviewing, reading, analyzing, and interpreting general business periodicals, professional journals, technical procedures, and governmental regulations
• o Expert in writing reports, business correspondence, and procedure manuals

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.