Address
Form of workJob Function:
Provide oversight, coaching, and mentoring of Supplier Quality Engineers (SQE's) who are responsible for collaborating with new product development teams in the development and integration of purchased components, services, and suppliers into the quality system.
SQE functional responsibilities include management of the supplier audit and component qualification processes, which include component specification development, risk assessment, inspection method development, test method validation, capability analysis, and process validations for critical outsourced processes.
Supervise staff and ensure appropriate coverage in support of new product development and ongoing oversight of supply base, including supplier development initiatives and timely resolution of quality issues.
Manage investigation, containment, and risk-based escalation (as appropriate) of nonconformance issues identified for purchased pre-commercial components
Provide effective oversight and review of supplier files to ensure compliance to new product development and supplier management processes.
Lead continuous improvement initiatives, including quality system and procedure adjustments, to elevate quality, compliance, and efficiency of the supplier qualification process
Manage personnel ensuring growth and professional development
A Bachelor's degree in an engineering, science, or technical discipline is required; master's degree is preferred. Must have a minimum of 10 years of experience with comparable responsibilities and previous management experience required.
Must have a background in Supplier Quality, supplier development or product development in medical devices
Expert knowledge of engineering procedures and demonstrated history of applying functional knowledge and existing methodologies to complex problems
Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements
Ability to prioritize, plan & evaluate deliverables to established strategic goals
Strong management and leadership skills to ensure management, growth and development of personnel
Excellent verbal and written communication and presentation skills with the ability to communicate business issues in an easy to understand manner
Demonstrated experience prioritizing conflicting demands in an extremely fast-paced environment
Strong problem solving, influencing and negotiation skills, ability to work well as a leader, independently and in a team setting
ASQ Certified Quality Manager, Quality Engineer, Quality System Lead Auditor, or related quality/regulatory certifications a plus.
