Job Description
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:
*Proven expertise in usage of MS Office Suite including MS Project; Electronic Quality Management System * Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
* Basic understanding of statistical techniques
* Team player and detail oriented.
* Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
* Strong problem-solving, organizational, analytical and critical thinking skills
* Substantial understanding of processes and equipment used in assigned work
* Good leadership skills and ability to influence change
* Knowledge of applicable FDA regulations for medical device industry
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Ability to manage competing priorities in a fast-paced environment
* Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Education/Experience:
* Bachelor's degree in engineering required.
* 5-7 years experience required.
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.
Job Tags
Hourly pay, Contract work, Local area,