Senior Manager, Quality Engineering
Responsibilities include:
Manage a team of Quality Engineering in leading the sustaining quality engineering activities for all the operations in tissue heart valve manufacturing for the Irvine plant.
Lead and support the efforts of identification and ensure the optimization of valve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) in design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
Acts as advisor to subordinate staff to help meet established schedules or resolve technical or operational problems. Consult the execution of Design Control activities for new product development in ensuring robust and efficient design transfer to production.
Manage, mentor and motivate subordinates to execute compliant work while meeting project timelines. Ensure appropriate QE resources are allocated.
Initiate and lead in the investigation of manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) through hands-on presence inside the clean room for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Requires close partnership with Manufacturing Engineering and Operations Supervisors.
Work through subordinates to determines equipment qualification, process validation, and product line design/modifications requirements, as well as requirements for testing procedures of raw materials, packaging materials, components and finished products. Drive the development and manage the execution experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
Formulates and maintains Quality Control objectives and coordinates objectives with Manufacturing to maximize product reliability and minimize costs.
Work with employees to insure they are adequately trained and understand their responsibilities. Help them in their career growth and development plans.
Engage with and collaborate with cross functional management to address project issues and obstacles and find appropriate solutions
Qualifications
Bachelor's degree in engineering field
Minimum of 12 years of experience in medical device or related industry
Six Sigma Black Belt, ISO Lead Auditor certification a plus
Expert understanding of quality engineering procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Good presentation, verbal and written communication skills
Accountability, solid decision making skills
Strong analytical, problem-solving, teamwork skills, innovative
Organization & project management skills
Knowledge of USFDA QSR/cGMP, ISO 13485, ISO14971
Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Ability to work independently with little or no supervision.
Ability to travel up to 20% of the time.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Manage a team of Quality Engineering in leading the sustaining quality engineering activities for all the operations in tissue heart valve manufacturing for the Irvine plant.
Lead and support the efforts of identification and ensure the optimization of valve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) in design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
Acts as advisor to subordinate staff to help meet established schedules or resolve technical or operational problems. Consult the execution of Design Control activities for new product development in ensuring robust and efficient design transfer to production.
Manage, mentor and motivate subordinates to execute compliant work while meeting project timelines. Ensure appropriate QE resources are allocated.
Initiate and lead in the investigation of manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) through hands-on presence inside the clean room for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Requires close partnership with Manufacturing Engineering and Operations Supervisors.
Work through subordinates to determines equipment qualification, process validation, and product line design/modifications requirements, as well as requirements for testing procedures of raw materials, packaging materials, components and finished products. Drive the development and manage the execution experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
Formulates and maintains Quality Control objectives and coordinates objectives with Manufacturing to maximize product reliability and minimize costs.
Work with employees to insure they are adequately trained and understand their responsibilities. Help them in their career growth and development plans.
Engage with and collaborate with cross functional management to address project issues and obstacles and find appropriate solutions
Qualifications
Bachelor's degree in engineering field
Minimum of 12 years of experience in medical device or related industry
Six Sigma Black Belt, ISO Lead Auditor certification a plus
Expert understanding of quality engineering procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Good presentation, verbal and written communication skills
Accountability, solid decision making skills
Strong analytical, problem-solving, teamwork skills, innovative
Organization & project management skills
Knowledge of USFDA QSR/cGMP, ISO 13485, ISO14971
Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Ability to work independently with little or no supervision.
Ability to travel up to 20% of the time.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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