Product Development (PD) will be responsible for: (1) quality assurance (QA) activities and documentation associated with new development and design changes to ensure compliance with the quality system and (2) participating as a stakeholder in the design process to ensure product specifications and development activities are aligned with the organizations quality objectives. This individual will provide oversight and generate quality documentation to ensure QMS compliance. As part of a project team, the Quality Engineer will be responsible for Quality assurance input to and review of design specifications, Supplier Qualification, Manufacturing Quality Plan, Risk Management activities, design verification and validation review, and audit Design History Files for compliance.
Key Responsibilities/Accountabilities
Representing Quality on new product development teams as the responsible individual for ensuring compliance with company quality and applicable regulatory requirements and standards.
Leading efforts and ensuring completion of Risk Management activities for new and/or modified products and processes authoring risk management plans and reports, facilitating risk assessment activities.
Working with Operations and RD to develop manufacturing quality plans and set quality standards for new and/or modified products and processes to ensure a high level of product quality.
Monitoring compliance to design control processes and procedures.
Reviewing and providing input for design verification and validation protocols and reports to ensure compliance with the quality management system.
Providing input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and evaluated.
Leading master validation planning sessions for projects of all levels of complexity.
Participating in the supplier selection process and implementing the appropriate supplier quality controls during the development processProviding post release input from the quality system (non-conforming material reports, yield, rework) or external sources (customer complaints), for post market surveillance.
Being able to work in a fast-paced environment.
Job Requirements
Bachelor's degree in science or engineering (industry experience may be considered).
3-5 multifaceted years of experience required, preferably in Product Research and Development as well as Quality Control or Quality Assurance in a Medical Device Company.
Ability to generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Experience in writing Validation and Verification Protocols and Reports (e.g. Design VV, Process VV and Gage RR).
Experience with inspection methods and specifying inspection equipment.
Preferred
Self-motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
Prefer certification as a CQE or CQM, and member of the ASQ.
Experience using quality tools and statistical programs (e.g., risk assessment (FMEA), experimental design (DOE) and statistical process control (SPC) is required.
Strong written, mathematical, collaboration, communication skills
Organizational skills as well as time management skills essential for project work.
Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, EU MDR and other medical device related standards.
Position and Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand.
Supervisory Responsibilities
This position does not have supervisory responsibilities.
Travel
Little to no travel is expected for this position
EEO Statement
Accelus is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. There is occasional exposure to shop elements such as noise, dust, odors, and fumes.
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. While performing the duties of this job, the employee is regularly required to communicate with individuals internally and external to the organization and read manuals and documents. The employee frequently is required to move about the warehouse as well as the entire facility. The employee may be required to lift up to 25 lbs. by themselves.
Other
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.