Manager Quality Engineering
Manager Quality Engineering
Posted on :
15-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
15-03-2025
Job Description
MannKind
MannKind Corporationfocuses 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 drypowder 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 MannKinds 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 subassemblies. 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 field and 5 years of work
experience in the job offered or related occupation in medical device industry.
SPECIFIC SKILLS:
MannKind Corporationfocuses 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 drypowder 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 MannKinds 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 subassemblies. 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 field and 5 years of work
experience in the job offered or related occupation in medical device industry.
SPECIFIC SKILLS:
- 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.
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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