New · posted Nov 4
Lsi Solutions · Medical Devices
Quality Engineer
- Victor, NY
- On-site
- Full-time
- Associate & Specialist
The role
LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.
We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.
ADDITIONAL RESPONSIBLITIES
- All other duties as assigned.
What you need
Quality Engineer I:
- Bachelor’s degree or higher in a technical discipline required.
- 0-3 years of relevant Engineering experience in medical device or other regulated industry preferred.
Quality Engineer II:
- Bachelor’s degree or higher in a technical discipline with 3 or more years of relevant experience in medical device or other regulated industry required.
Senior Quality Engineer:
- Bachelor’s degree or higher in a technical discipline with 7 or more years of relevant Quality experience in medical device or other regulated industry required.
- Master’s degree in a technical discipline with 5 or more years as a Quality Engineer.
KNOWLEDGE, SKILLS & ABILITIES
The following apply to all Quality Engineer levels:
- Knowledge and application of ISO 13485.
- Strong problem solving, root cause analysis and analytics skills.
- Familiarity with quality engineering concepts and tools, e.g. Statistical Process Control (SPC), Capability Analyses, Design of Experiments (DOE’s), and Process Control Plans (PCP).
- Geometric Dimensioning & Tolerancing (GD&T) Fundamentals.
- Familiarity with Gauge Repeatability and Reproducibility (R&R) for gauging and fixturing.
- Strong proficiency in MS Word, Excel, and Outlook.
- Strong written and verbal communication skills.
DIFFERENTIATING KNOWLEDGE, SKILLS & ABILITIES
Quality Engineers each report through a particular focus of the Quality Management System. All of the knowledge, skills, and abilities listed above are required for all focus areas. The following additional KSAs are required based on specific focus areas.
- Experience in documenting and reviewing risk assessments.
- Experience in terminal sterilization.
- Experience in cleanroom environmental monitoring.
- A strong working knowledge of ISO 11135 and/or ISO 14644.
- Experience in technical transfer of product to manufacturing preferred.
What you'll do
Quality Engineer I
- Assist in the development of Quality Management System (QMS) processes and procedures to ensure compliance with applicable regulations.
- Coordinate and disposition non-conforming product.
- Perform data analysis, and develop, monitor, and oversee metrics reporting.
- Lead and/or support continuous improvement activities.
- Support and participate in internal and external audits and inspections.
- Generate and maintain procedures, work instructions, inspection plans, forms, and templates.
- Lead and/or participate on Corrective Action and Preventive Action (CAPA) investigations.
- Review/approve verification & validation protocols and reports.
Quality Engineer II
- Demonstrate knowledge in the Quality Engineering functions listed above, plus:
- Lead Activities for the development of the QMS.
- Responsibility and ownership for product line and/or process Quality Engineering deliverables.
- Lead continuous improvement activities.
- Lead Corrective Action and Preventive Action (CAPA) investigations.
- Work independently as a self-starter with minimal direction.
Senior Quality Engineer
- Demonstrate advanced knowledge in the Quality Engineering functions listed above, plus:
- Act as a team lead for Quality Engineers or subject matter expert in a critical field of the Quality Management System (QMS).
- Identify areas for improvement within the QMS and lead/implement activities for improvement.
- Able to teach and mentor Quality Engineers in the use of key Quality concepts.
DIFFERENTIATING ESSENTIAL FUNCTIONS
Quality Engineers each report through a particular focus of the Quality Management System. While most of the essential functions are universal, the following responsibilities are driven by this difference in reporting structure.
Finished Goods:
- Conduct finished goods health risk assessments.
- Maintain sterilization validations, and act as sterilization subject matter expert for new product development.
- Maintain and improve environmental monitoring program.
- Develop and maintain process monitoring of Finished Goods team QMS processes.
- Develop and maintain product/process monitoring of LSIs finished goods products and processes.
- Analyze product and process monitoring data to identify opportunities for improvement. Coordinate improvements in finished goods work centers.
- Provide input to the maintenance of pFMEA, PFD, control plans.
Pay and benefits
$66,500 a year
Employer providedSALARY PAY RANGE
JOB SUMMARY: Perform quality engineering tasks for new & existing product and process development and improvement initiatives. Quality Engineers are specialized in either Supplier Quality Engineering, Design Quality Engineering, Metrology Quality Engineering or Finished Goods Quality Engineering. Quality Engineers interface with other functions within an organization and with internal and external customers and suppliers on quality-related issues.
REPORTS TO: Quality Manager
SUPERVISES: N/A
LSI SOLUTIONS® BENEFITS INCLUDE
Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts
15 Paid Holidays, PTO, Sick Time
Medical, Dental, Vision effective first day of employment
Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Where you'll work
Victor, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Victor, NYSchedule and working conditions
Days
Hours
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Frequently required to lift, carry, push and/or pull from 10-20 lbs.
- Ability to periodically bend or kneel and use color vision/depth perception.
- Sitting, standing and/or walking for up to eight (8) hours per day.
- Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
- Regularly required to talk and/or hear.
- Ability to travel to suppliers on average 25% to support responsibilities defined above (for external Supplier function only).
Equal opportunity, accessibility and legal noticesLsi Solutions's statements, word for word
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% below the US median for Quality Engineering roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $66,500 | — | $66,500 |
| All US (middle half) | $73,000 | $84,000 | $99,000 |
This role: Lsi Solutions's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 211 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not LSI Solutions's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 52 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk13
- Collaboration and leadership11
- Documentation and SOPs6
- Investigations and CAPA4
- GMP and compliance3
- Validation and qualification2
- Lab testing and methods1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care productsNamed in the posting
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentrationNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
Company hiring pulse
LSI Solutions on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Associate & Specialist2 67%
- Manager1 33%
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Open until filled. $67K a year, employer provided.