Job Description
Yoh has an immediate,
4- month contract opportunity, as a Post Market Engineer , within the Medical Device Industry to our client, Onsite strongly preferred to report to from their office in Gainesville, FL ***This role is a W2 and is not STEM/OPT or H1B eligible***
***Local candidates will be considered before remote**
- $100-135/hr. max hourly rate
- 40 hours, Mon-Friday
- Medical Device or Pharmaceutical FDA regulated environment, Complaint Investigation & Engineering problem-solving techniques during complaint investigation activities
Performs complaint product analysis and root cause investigation in support of client and regulatory requirements.
What You Will Be Doing
- Applies strong/solid foundation in Root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone diagrams, Fault Tree Analysis)
- Performs complaint product analysis and testing per Exactech's procedures and requirements.
- Performs complaint root cause analysis and supports conclusions with objective evidence and sound rationale.
- Performs complaint risk analysis and complaint history reviews.
- Escalates complaint investigation findings, as appropriate and per Exactech's procedures and requirements.
- Documents all complaint investigation, coding, and escalation activities per Exactech's procedures and requirements.
- Coordinates the initiation of new complaints and regulatory reporting, as determined during investigation.
- Supports the completion of complaint activities in line with department metrics and key performance indicators.
- Knows and applies client Quality System requirements and any appropriate FDA and international standards.
- Assists and supports other elements of the complaint handling process as directed.
Who You Are - Bachelor’s Degree in an Engineering discipline from an accredited institution required.
- Must have an understanding of root cause and risk analysis as well as technical writing.
- Previous experience in the Medical Device or Pharmaceutical FDA regulated environment required; product complaint investigation and handling preferred.
- Experience with FDA/ISO quality management system regulations.
- Must have excellent communication (verbal & written) skills.
- Must have excellent interpersonal skills and must be able to work effectively in a team environment.
- Must be detail-oriented and have the ability to consistently meet high standards of input accuracy, produce quality documents, and perform analyses with accuracy.
- Strong organisational and time management skills.
- Self-directed; capable of setting own priorities and working independently to meet established deadlines.
- Must have knowledge of various software packages including Microsoft Office applications.
If This Sounds Like You, Apply Now!
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK.
Estimated Min Rate : $100.00
Estimated Max Rate : $135.00
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.
Job Tags
Hourly pay, Contract work, Local area, Immediate start, Remote job, H1b,