Job Description

Job title: Senior Quality Engineer / Quality Engineer
Status: Exempt

Job Summary

 
restor3d is a fast-growing company bringing innovative technology to our patients and surgeons, expanding the reach of personalized medicine. The Quality Engineer will be responsible for assisting in the development, implementation, and oversight of the quality system of the company while providing support to operations/manufacturing, manufacturing engineering, and product development. This role will have a direct impact on the long-term future of restor3d. This role is an on-site position at our Wilmington, MA location.

 
Duties and responsibilities

 
•    Implement quality system processes to support production of safe and effective implantable medical devices and to adhere to applicable regulatory requirements.
•    Identify and implement solutions of continuous improvements for the quality system, Quality Control inspection lab, manufacturing processes, and product designs.
•    Develop and maintain strong internal working relationships across the company.
•    Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
•    Write, review and approve, and communicate quality system documentation updates to SOPs, Work Instructions, and Quality Inspection Plans.
•    Participate in supplier selection and approval process, including supplier audits and review of quality data. 
•    Assist with the Corrective/Preventive Action (CAPA) program and Customer Complaint system by investigating failures and opportunities for improvement, including root cause analysis and risk assessments.
•    Initiate, review, and perform root cause investigations for nonconformities related to processes and/or the quality system, identifying actions(s) needed to correct or prevent recurrence, verifying and validating the action(s) to ensure effectiveness, and disseminating information related to nonconformities to those directly responsible.
•    Contribute to design and process verification and validation activities including equipment IQ/OQ/PQ, test method qualification, acceptance criteria, and statistical principles. Assists in writing and reviewing protocols, reports, and operating procedures to support product and process development.
•    Supervise and perform risk management activities including creation and maintenance of risk management files by product and process as the key quality representative for those tasks.
•    Support Product Development teams as the quality subject matter expert, provide review and approval of product Design History Files, and actively participate in Design Control Phase Reviews.
•    Establish and trend quality metrics, analyze data, and assign actions to help organization meet quality KPI goals. 
•    Participate in hosting inspections by regulatory authorities (e.g., FDA) and ensure all observations are appropriately addressed.
•    Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements and drive improvements to the QMS in response to observations.
•    Assist with product inspections as needed.
•    Performs other related duties as assigned.

Qualifications and experience

 
Required Skills: 
•    Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. 
•    Ability to make rapid, risk-based decisions, prioritize and plan work activities, and adapt for changing conditions.
•    Excellent written and verbal communication skills.
•    Able to work accurately in a fast-paced and ever-changing environment with strong attention to detail.
•    Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
•    Strong influencing, organizational, analytical, and time-management skills.
•    Able to self-motivate and work both independently and as part of a team.

Education and Experience:
•    Bachelors or Masters degree in Engineering, Science, Mathematics, Biomedical, or Materials Science. 
•    3 – 10 years of experience with a comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820 and other applicable international standards with hands on experience in working within a quality system under regulatory requirements including a background in device design, testing, and FDA clearance.
•    Proficiency with Microsoft Office (Word, Excel, PowerPoint). 
•    PowerBI or other data visualization experience a plus.
•    SOLIDWORKS experience is a plus.
•    ASQ, CQE, and CQA Certifications or related quality/regulatory certification a plus.
•    Six Sigma Green/Brown/Black Belt Certification a plus. 
•    Ability to travel as needed (≤ 10% of the time).
Physical Requirements: 
•    Position may involve the use of basic hand tools and inspection and cleaning equipment
•    Position may involve handling of or exposure to metallic powders, mill coolant, tapping fluid, and polymeric resins.
•    Limited physical requirements other than general skills required to participate in laboratory experiments, production activities, or other similar activities.
•    Standard working conditions, including office environment, laboratory, aseptic surgical (when visiting surgical centers and viewing surgeries), and general travel.
•    Prolonged periods sitting at a desk and working on a computer.
•    Must be able to lift up to 15 pounds at times. 

 

Job Tags

Full time,

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