Sr. Engineer

We are seeking a Post Market Surveillance and Risk Management Engineer to work on a team at our client site in Irvine, CA. No 3rd party candidates can be considered. This is a contract to hire position, so it will start as a W2 hourly position with Roth Staffing (parent company of Ledgent Technology).

Pay Rate : $60.37 / hr.

Day to day

This role specifically would be investigating complaints - business unit is surgical (class III). Team does not do intake / MDR reporting, but rather does the investigation and robust root cause analysis.

Set timelines to investigate complaints - working with R&D, manufacturing, supplier, etc.

Complaints volume - around 100 a month.

Additional post market surveillance activities as time permits, residual risk, etc

Technical skills

Root cause investigations (CAPA backgrounds), problem solving

Good documentation skills - technical writing exp would be helpful and beneficial

Experience in complaint investigations / handling.

Post market quality experience

Class III device exp

Job Description : Summary :

The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.

Job Responsibilities :

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
• Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.
• Lead Post Market Surveillance activities for products approved in EU.
• Oversight of all complaints that require investigation through the different phases.
• Ensure on time completion of complaints.
• Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.
• Ensure complaint investigations are adequate and comply with applicable procedures.
• Develop, update, and maintain technical content of risk management files
• Other incidental duties assigned by Leadership

Skills :

Education / Experience :

Desired Skills and Experience

Team covers - Complaints, post market surveillance, risk management. Quality and fast paced environment

9 people on the team with an open FTE role to make 10, the contingent would be 11

4 QE II, 5 Senior Engineer, and the open FTE is for a Principal QE

Day to day

This role specifically would be investigating complaints - business unit is surgical (class III). Team does not do intake / MDR reporting, but rather does the investigation and robust root cause analysis.

Set timelines to investigate complaints - working with R&D, manufacturing, supplier, etc.

Complaints volume - around 100 a month.

Additional post market surveillance activities as time permits, residual risk, etc

Technical skills

Root cause investigations (CAPA backgrounds), problem solving

Good documentation skills - technical writing exp would be helpful and beneficial

Experience in complaint investigations / handling.

Post market quality experience

Class III device exp

Tools / Software - no particular tools stand out to the HM.

Minitab is a nice to have.

CAD / Creo are not specific requirements either

Soft Skills

Really needs a strong team player - team is very cohesive, open learning environment, hit the ground running

Able to work with different groups and collaborate

Resume Highlights

Engineering degree - what kind of engineering degree doesn't matter as much

5+ years of exp with a bachelor degree, 2+ years of exp with a Masters degree. Class III device exp

Process improvement (green or black belt)

ASQ Certification is also a nice to have

Variety of different backgrounds (mixed experience and learning different things), but not hopping around every year

Experience in this area - investigating complaints on class III

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.