Quality Engineer - restor3d

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.
• 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.
• Prioritize and plan work activities; adapt for changing conditions.
• Assist in maintaining the quality system in accordance with applicable regulatory requirements.
• Write, review and approve, and communicate quality system documentation updates to SOPs, Work Instructions, and Quality Inspection Plans.
• 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.
• Perform Internal Quality Audits of the quality system.
• Participate in supplier selection and approval process, including supplier audits and review of quality data. 
• Assist with product inspections as needed.
• Participate in cross-functional product development teams.
• Participate in product/process validations.
• Perform risk assessments, gathering cross-functional team input.
• 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.
• Performs other related duties as assigned.

 
Qualifications and experience
 
Required Skills: 

• Ability to make rapid, risk-based decisions.
• 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.
• Must have a solid knowledge of Microsoft Office.
• Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
• Excellent organizational skills, with the ability to prioritize work.

 
Education and Experience:

• Bachelor of Science in Engineering, Mechanical Engineering, Science, Biomedical, or Materials Science. 
• 0 – 5 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). 
• Ability to travel as needed (≤ 10% of the time).
• 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.

 
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.