Manager, Quality Engineering

• Support Quality, Operations, RandD, and Supply Chain in achieving and adhering to product quality requirements, project goals on objectives, and Quality System improvement initiatives. Participate in supplier quality activities including supplier qualifications, supplier performance reviews, supplier audits, Quality Agreements, Failure investigation, supplier quality metrics and supplier evaluations, risk assessments and Supplier Corrective Action Request (SCAR) resolutions. Define, develop, and manage required communication and rollout plan for addressing supplier capability deficiencies, etc. Implement, and monitor supplier development initiatives, including supplier performance management. Provide guidance to suppliers on MannKind's quality requirements and ensure suppliers provide thorough information for sustaining new product development projects such as First Article Inspections, PFMEA, control plans, contingency planning, Validation activities and Process Capability Studies. As well as evaluate protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Ensure continuous timely release of finished product through review and approval of manufacturing and inspection records (i.e.- test reports, DHRs, etc.). Manage the Incoming Inspection processes including supplier certification for raw materials, components and sub-assemblies. Lead the Nonconforming Material process by overseeing the investigation, root cause analysis, corrective/preventive action establishment, and final material disposition and closure of NCMRs. Assist Quality Systems, as appropriate, in management of process and RandD equipment. Support Risk Management activities (Hazards Analysis, DFMEA, PFMEA, etc.) as the technical Quality lead. Gather, compile, track, analyze and report on Quality data and metrics as appropriate and assigned by Management. Other duties as assigned by manager.

Telecommuting is allowed.

• This position requires a Bachelor degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, Electrical Engineering or closely related filed and 5 years of work

experience in the job offered or related occupation in medical device industry.

• Must possess expertise/ knowledge sufficient to adequately perform the duties of the job being offered. Expertise/ knowledge may be gained through employment experience or education.

Such expertise/ knowledge cannot be "quantified" by "time." Required expertise/ knowledge includes:

Quality Management System regulations and requirements including FDA 21 CFR 820, ISO 13485, etc.

Risk Management requirements and tools (i.e. ISO 14971).

Understanding of product and process verification and validation.

Participate in the management of product market complaints and conduct market complaint investigations.

Support and participate in audit/inspection activities to ensure compliance with regulatory requirements.