Manager, Quality Engineering

6. Job Responsibilities

.Manages Quality Engineering staff and guides the Quality groups in BD TCI in support of product development.

.Leads development, sustenance, and continual improvement of quality systems in compliance with 21 CFR 820, EUMDR, and ISO 13485 quality systems with a specific focus on the design control requirements.

.Runs multiple projects directly while managing other quality engineering resources running separate projects.

.Ensures compliance with all local, state, federal regulations, and BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.

.Leads design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process.

.Leads or supports cross-functional planning, coordination, and reviews. Initiates and directs QA/ QS programs for effective introduction of new products and processes to fulfill the strategic plan.

.Leads Risk Management activities for products under design authority.

.Supports quality initiatives for Site issues. Work closely with Design Owner and Manufacturing sites globally to resolve customer complaint issues by identifying root causes and developing corrective actions.

.Act as a role model/Change ambassador to establish Inspire Quality initiatives through close collaboration with many partners to influence and lead the Quality strategy

.Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA)

7. Knowledge and Skills

a. Knowledge

.Bachelor's degree in mechanical engineering or related discipline.

.Advanced knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, ISO 14971, EUMDR etc.), and quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.

.Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.

.Advanced leadership, motivational, and team building skills, with the ability to lead organizational change.

.Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization.

.Understanding of clinical setting and ability to understand customers quality and regulatory needs.

.Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment.

b. Skills

.Minimum 5 years of experience in supervising technical/ quality professionals.

.Minimum 10 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing, and CAPA systems, including or other applicable combination of education and experience.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift