Quality Engineer
Job DescriptionRoles &
Responsibilities:
Support the development of the Company's quality objectives work in conjunction with the company employees to ensure ISO/QSR compliance Participate in regulatory and quality audits as required to maintain ISO/QSR compliance Collaborate with internal and external partners e.
g.
laboratories, manufacturers, packagers, to provide medical devices that meet quality requirements for new and existing products Work with product development and operations to design and produce labeling, work instructions, test methods, instructional and promotional materials that comply with quality requirements Perform administrative activities associated with the department.
This will include DHR review, Client and CAPA generation and processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review Analyzes process non-conformances and implements comprehensive corrective and preventive action plans Actively comply with Medcura's Quality System Medcura is a startup entrepreneurial environment, and each employee may be asked to assist in work in areas outside of their usual duties.
This is an expectation of each employee.
Education & Experience :
Four-year degree in engineering or related technical degree A minimum of 4 years relevant work experience in the medical device field or related industry Experience in process improvement engineering or product / process improvement areas is preferred Experience in Quality function or with responsibility for ownership of quality system elements within role(s) is preferred Working knowledge and understanding of QSR, ISO (13485), FDA and EU MDR and other medical device industry quality requirements.
Must be able to understand and apply regulated principles in work experiences.
American Society of Quality (ASQ) certification (CSQE, CQE, CQA, etc.
) a plus/preferred Ability to follow instructions in performing repetitive tasks.
Attentiveness in performing tasks Ability to work as a team member in manufacturing and quality custom polymer based gels Skills & Abilities:
Excellent verbal and written communication skills Team-oriented individual with strong interpersonal skills, management and leadership skills Strong leadership, excellent organizational skills, and a good blend of discipline and creativity Solid analytical skills and the ability to problem solve quickly Knowledge of chemical processing and batch production Commitment to company with ability to function within a start-up environment Understanding of FDA requirements and ISO 13485 Recommended Skills Administration Advertising Analytical Auditing Business Process Improvement Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Support the development of the Company's quality objectives work in conjunction with the company employees to ensure ISO/QSR compliance Participate in regulatory and quality audits as required to maintain ISO/QSR compliance Collaborate with internal and external partners e.
g.
laboratories, manufacturers, packagers, to provide medical devices that meet quality requirements for new and existing products Work with product development and operations to design and produce labeling, work instructions, test methods, instructional and promotional materials that comply with quality requirements Perform administrative activities associated with the department.
This will include DHR review, Client and CAPA generation and processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review Analyzes process non-conformances and implements comprehensive corrective and preventive action plans Actively comply with Medcura's Quality System Medcura is a startup entrepreneurial environment, and each employee may be asked to assist in work in areas outside of their usual duties.
This is an expectation of each employee.
Education & Experience :
Four-year degree in engineering or related technical degree A minimum of 4 years relevant work experience in the medical device field or related industry Experience in process improvement engineering or product / process improvement areas is preferred Experience in Quality function or with responsibility for ownership of quality system elements within role(s) is preferred Working knowledge and understanding of QSR, ISO (13485), FDA and EU MDR and other medical device industry quality requirements.
Must be able to understand and apply regulated principles in work experiences.
American Society of Quality (ASQ) certification (CSQE, CQE, CQA, etc.
) a plus/preferred Ability to follow instructions in performing repetitive tasks.
Attentiveness in performing tasks Ability to work as a team member in manufacturing and quality custom polymer based gels Skills & Abilities:
Excellent verbal and written communication skills Team-oriented individual with strong interpersonal skills, management and leadership skills Strong leadership, excellent organizational skills, and a good blend of discipline and creativity Solid analytical skills and the ability to problem solve quickly Knowledge of chemical processing and batch production Commitment to company with ability to function within a start-up environment Understanding of FDA requirements and ISO 13485 Recommended Skills Administration Advertising Analytical Auditing Business Process Improvement Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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