Design Quality Engineer – Orthopedics
Yochana · Palm Beach Gardens, FL
- Level
- Engineer
- Team
- Quality
- Degree
- Required
- Experience asked
- 10+ years
- Certification
- Black Belt preferred
- Industry
- Industrial
- Posted
- Recently
The role in 30 seconds
An engineer-level quality role at Yochana (industrial) in Palm Beach Gardens, FL. Verification & Validation (V&V): Approve design verification/validation plans, protocols, and reports to ensure compliance with product requirements, including mechanical testing, tolerance analysis, and anatomical lab testing.
- They ask for
- 10+ years · degree required · Black Belt preferred
- Tools it names
- Six Sigma, Black Belt, Root cause, FMEA, GD&T, Minitab
Read from the posting. The full description is below.
From the plant jobs report · week of November 9, 2026
Quality Engineer roles in Florida: typical posted base $85k–$158k.
Median of the low and high ends of 14 live postings that list pay, out of 67 quality engineer openings in Florida, read from manufacturers' own careers sites.
Florida plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 66 other live quality postings in Florida.
- Base pay
- Not listed in this posting
- Experience asked
- More than usual (10+ vs 5+)
Typical $85k–$158k, from 14 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 61%
- Lean 42%
- ✓ Six Sigma 36%
- AS9100 34%
- SPC 31%
- Supplier quality 30%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for Minitab, ISO 13485, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Yochana
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- The posting mentions a Black Belt. Does the company sponsor certification?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
Full description from YochanaAs posted on their careers site.ShowHide
Responsibilities
Design Control Leadership: Lead and support Design Control activities (planning, design inputs, outputs, verification, validation, and design transfer) across the product lifecycle.
Risk Management: Facilitate and lead risk management activities, including development of Risk Management Plans, Hazard Analysis, and Design Failure Mode Effects Analysis (DFMEA) for orthopedic products.
Verification & Validation (V&V): Approve design verification/validation plans, protocols, and reports to ensure compliance with product requirements, including mechanical testing, tolerance analysis, and anatomical lab testing.
Design Transfer: Ensure the successful transfer of new products to production by assisting in process validation
requirements
(IQ/OQ/PQ) and reviewing manufacturing documentation.
Technical Documentation & Audits: Review and approve Design History Files (DHF) and Device Master Records (DMR) for conformance. Support internal and 3rd party audits (FDA/Notified Body).Post-Market Surveillance (PMS): Utilize post-market data and analytics to report on product performance in the field, providing feedback to R&D for continuous improvement.
Root Cause Analysis: Lead quality-related problem-solving and root cause investigations for design-related issues, complaints, and CAPAs.
Regulations: Strong understanding of FDA 21 CFR 820, ISO 13485, and ISO 14971.Technical Skills: Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and machining methodologies (titanium and stainless steel).Tools: Proficient in statistical software tools (e.g., Minitab) for data analysis and risk analysis.
Education and Experience
Bachelor's degree in mechanical or biomedical Engineering with 6 to 10 years of experience in medical device. ORMaster's degree in mechanical or biomedical Engineering and 6+ years of experience.
Show full description ↓Show less ↑
Design Quality EngineerThe Design Quality Engineer will act as the quality representative and design control lead on cross-functional new product development (NPD) and sustaining engineering teams. This role ensures that orthopedic implants and associated instrumentation are developed and manufactured in compliance with internal QMS, FDA 21 CFR 820, ISO 13485, and ISO 14971 standards. The ideal candidate will facilitate risk management activities, verify design outputs, and ensure a smooth design transfer to manufacturingKey
Skills
Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt.
Experience with EU MDR regulatory submissions.
Experience with surgical instrumentation and/or implantable devices.
Core Competencies
Strong analytical, problem-solving, and critical thinking skills. Effective communication and interpersonal skills to work within multi-disciplinary, cross-functional teams. Detail-oriented with a focus on compliance and accuracy.