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Quality Engineer

Medical Microinstruments

Jacksonville, FL, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Industry: Life Science
  • Post Date: 06/10/2024
  • Website: mmimicro.com
  • Company Address: Via del Paduletto, 10a, 56011 Paduletto PI, Italy

About Medical Microinstruments

MMI has developed the first teleoperated robotic platform for suturing in open surgery with wristed microinstruments.

Job Description

Want to join a motivated global team of 200+ people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced, medical device industry in a new and exciting field of robotic micro-surgery?

 

Medical Micro instruments (MMI) is looking for an experienced Quality Engineer professional to bring its breakthrough technology in the US. The incumbent will interface with cross-functional stakeholders both here in Jacksonville as well as a sister plant in Italy to ensure that processes are implemented and data/metrics generated is recorded, reviewed, and communicated. They will also act as a technical and system knowledgeable resource in all matters related to the quality and reliability of MMI’s processes and products. This is an important individual contributor position within the MMI Quality Team that will be accountable for working relationships within MMI along with driving Quality System compliance and Continuous Improvement.

 

Position highlights:

  • Delivering key support with system compliance and post market activities.
  • Considerable knowledge and experience in Quality application and Quality Systems in support of FDA and Regulatory requirements.

 

Core Responsibilities:

  • Review & approve drawings, specifications, manufacturing instructions, and bills of material for completeness, accuracy, reproducibility, and compatibility with existing documentation.
  • Participate in ECO sign-off and approval.
  • Perform Risk Management activities (FMEA, Hazard Analysis, etc.).
  • Manage the completion of validation protocols and test plans (IQ, OQ, PQ, test method and inspection method qualification), including the specific performance of compliance testing.
  • Participate and support in Product Development activities (design reviews, design verification and validation, etc.).
  • Collect, analyze, and take action on performance measurement indices, statistical capability / reliability analysis.
  • Disposition non-conforming material (QE/NCMR).
  • Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA).
  • As appropriate, assist in supplier management (surveys, visits, and supplier corrective action).

 

Required skills and experience:

  • Bachelor’s degree (Engineering or Medical /Biomedical background).
  • A minimum of 3-5 years working experience in Quality Assurance medical device industry.
  • Technical skills including the ability to read technical specifications; utilize measurement tools & equipment.
  • QSR and IS013485 experience required.
  • Must have experience in CAPA, NCMR, validation (IQ, OQ, PQ, etc.), DMR, DHR, risk management activities, statistics and design controls.
  • Fluent in English.
  • High level technical writing skills Interfaces with all departments in the organization in matters related to the quality system compliance and functional performance of product.
  • Ability to effectively interact with peer level individuals in other departments and senior management. Takes direction from departmental management.
  • Excellent record in collaboration with R&D and non-R&D functions as well as consultants and other partners

 

Preferred skills and experience:

  • Computer literacy (MS Office, Visio, Minitab, etc.).
  • Experience with IEC 60601 Medical Electrical Equipment, ISO 62304 Medical Device SW and ISO 62366 Usability.
  • Additional language.
  • Good understanding of manufacturing practices.
  • Self-motivated and able to work independently or as part of a team.
  • Strong organizational skills, detailed oriented.
  • Excellent writing skills to develop clear and logical information and conclusions based on design documentation.
  • Strong communication and presentation skills.
  • Demonstrated interpersonal skills including strong negotiation skills.
  • Ability to handle competing priorities effectively.
  • Ability to negotiate and resolve conflicts.

 

What We Offer

 

An exciting and challenging role where you will make a true impact in both the success of the company and patient lives. Work in a fun and growing company that is dedicated to a culture of diversity, equity and inclusion. Be a part of a company that is reinventing opportunities for micro and super-micro surgical procedures and outcomes. At MMI, we know that our people are our greatest assets and strengths, which is why we pride ourselves on creating a culture of transparency, respect, inclusion, and fun!

 

We also offer:

 

· Competitive Salary

· Inclusive Benefits Package

· Unlimited PTO

· 401k with 6% matching

· Flexible work/life balance

 

MMI is committed to creating a diverse work environment and is proud to be an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, pregnancy, age, disability or other characteristics protected by law.

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