Quality Manager

About the job

The Quality Manager will use multidisciplinary engineering knowledge to design, develop, verify and monitor innovative medical devices or components/subsystems in support of company’s strategic plan. This role will support and lead quality objectives by planning, managing, implementing and ensuring continued compliance with the quality system.

Major duties and responsibilities:

• Support quality operations to ensure continued compliance with applicable regulations/standards and provide the necessary training to ensure awareness of personnel
• Contribute to quality initiatives and functions to ensure effectiveness of the quality management system, including but not limited to, product and process monitoring, data analysis and applying statistical techniques, audit support, purchasing and verification, control of equipment, etc.
• Act as management representative and report the effectiveness of the QMS to top management
• Perform quality functions such as procedure writing, inspection, testing and reviewing documents for accuracy and application of procedures or standards
• Assess opportunities for improvement and need for changes to the quality system by systematically monitoring and reviewing data pertaining to the organization, product or process changes, non-conforming product, changes to regulations/standards, complaints and feedback
• Own and support activities pertaining to complaint handling, vigilance and medical device incident reporting by understanding and implementing the requirements based on the regions SMM markets its devices and documenting/addressing complaints in a timely manner to ensure compliance with the applicable regulations
• Qualify suppliers and monitor supplier performance to ensure product meets specified requirements
• Lead investigations, root cause analysis, and determination of required action to be taken in response to non-conforming product or quality system processes using a risk based approach
• Assist in the development of dFMEAs (Design Failure Mode Effect Analysis) and pFMEAs (Process Failure Mode Effect Analysis) and control plans where required.
• Facilitate validations and component acceptance activities
• Maintain traceability, identification, documentation and applicable records to provide evidence of product and processes meeting requirements
• Apply broad engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
• Solve multidisciplinary engineering problems at the component through system level.
• Conduct testing utilizing existing test protocols or develop new ones as needed.
• Complete projects (including product enhancements) in a manner consistent with corporate objectives.
• Contribute to the intellectual property position of the company via invention and patent applications.
• Maintain accurate documentation of concepts, designs, drawings, and processes.
• Ability to coordinate and manage project design history file and associated activities.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
• Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
• Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
• Provide multidisciplinary engineering support in the resolution of product complaints and/or safety issues.
• Provide guidance to associate engineers and technicians on engineering/test activities.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable regulatory requirements.

Education/Experience requirements:

• A 4-year degree in engineering, scientific discipline, or similar.
• 5-10 years engineering experience supporting a medical device or related environment
• 1-2 years experience in QA/QE Management or Senior level position (Preferred)

Other qualifications:

• Knowledge of national and international regulations applicable to medical devices including; 21 CFR 820 (Quality System Regulations), ISO 13485, MDD 93/42/EE, and MDR 2017/745
• Working knowledge of engineering terminology and concepts and related software applications (Word, Excel, Project, Solidworks/CAD, Statistical software)
• Ability to interact effectively (both verbal and written) with associates across all departments within an organization at all levels
• Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail
• Must have demonstrated initiative and ability to work independently and under supervision of senior-level employees while handling multiple task

Physical demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to stand, walk and sit for extended periods of time.  Occasionally the employee will be required to lift or move at least 50 pounds.  Spending extended periods of time under a microscope.  Travel may be expected upwards to 25% of time.

To Apply:

Interested candidates should submit their resume to careers@shapemem.com with the job title as the subject.
Resumes from recruiters will not be accepted.