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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.

POSITION TITLE: Quality Engineer I, II Sr.

SHIFT HOURS: 8:00am to 5:00pm

SALARY RANGE: $75,000 to $110,000

The Role: Quality Engineer – Finished Goods

We’re looking for a technical, curious, and hands on Quality Engineer to join our Finished Goods team. You’ll be part of the group that ensures our devices are built right every time from cleanroom assembly through sterilization and final release.

This isn’t a desk-only job. You’ll spend time on the production floor, collaborating with cross functional teams, investigating issues, and figuring out how to make things better, faster, and safer, all with Quality in mind.

What You’ll Do

+ Troubleshoot manufacturing issues for all of our production lines, with a focus in suturing and suturing devices in Class 8 Cleanrooms

+ Work with labeling and labeling software, understanding the details that matter in a regulated environment

+ Maintain Packaging integrity testing and documents including monitoring

+ Support sterilization and environmental monitoring programs

+ ISO 13485 and FDA 21 CFR 820 knowledge

+ Perform root cause investigations and assist in implementing corrective actions via Non-Conformance (NCR) Module and CAPA

+ Analyze product and process data to spot trends, prevent issues, and drive continuous improvement

+ Participate in audits, validations, and change controls with a calm, confident, thought based approach

+ Partner with manufacturing/operations, engineering, and R&D for Quality guidance and support

Who You Are

+ A problem solver with critical thinking skills

+ Quick learner and take initiative with minimal direction

+ Comfortable with technical detail while understanding and maintaining the quality impact

+ Able to balance compliance with practicality knowing when to push back and when to adapt

+ Enjoy working in a fast-paced, team-oriented environment with people who care about what they do

What You Bring

+ BS in Engineering (Required), Life Sciences, or similar technical field

+ Experience in medical device, pharmaceutical, or other regulated manufacturing industry

+ Familiarity with ISO 13485, FDA QSR, sterilization, or labeling systems

+ Prior experience in Medical devices specifically suturing and/or labelling is preferred but not a requirement

Why You’ll Love Working Here

+ Work on products that actually improve patient outcomes

+ Be part of a tight-knit quality team that collaborates, not competes

+ Get involved in projects that make a visible difference

+ Competitive pay, full benefits, growth potential, and a company that invests in its people

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

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.

+ 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).

GENEROUS LSI 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, Vision and Dental effective first day of employment

+ Employee Referral Bonuses

LSI SOLUTIONS® is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic.

Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran