Manager, Quality Engineering

MannKind

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

DUTIES: Support Quality, Operations, R&D, 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 R&D 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.

REQUIREMENTS:

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.

SPECIFIC SKILLS:

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