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 ultimate customer is the patient.

JOB TITLE: Supplier Quality Engineer II or Sr. (Days 8am to 5pm)

SALARY RANGE: $85,000.00 - $105,000.00

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, Quality Engineering. Quality Engineers interface with other functions within an organization and with internal and external customers and suppliers on quality-related issues.

ESSENTIAL FUNCTIONS:

Quality Engineer II:

• 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 activities for the development of the QMS.

• Responsibility and ownership for product line and/or process Quality Engineering deliverables.

• Lead and/or support continuous improvement activities.

• Lead and/or participate on 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.

  Supplier:

• Qualify new suppliers through the PPAP process.

• Issue and implement SCAR’s (Supplier Corrective Action Reports).

• Lead supplier audits.

• Develop and maintain Supplier Performance Reports/Metrics for review and coordinate escalation activities.

  ADDITIONAL RESPONSIBLITIES:

• All other duties as assigned.

  EDUCATION & EXPERIENCE:

  Quality Engineer II:

• Bachelor’s degree or higher in a technical discipline with 4 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 KSAs apply to all Quality Engineers:

• 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.

  Supplier:

• Knowledgeable in Regulatory standards and auditing techniques associated with ISO, 9001, ISO 13485, ISO 17025 and MDSAP.

• Working knowledge of Quality Management Systems.

• Experience with process flows and component validation tools such as PPAP or IQ/OQ/PQ.

• Strong written and verbal communication skills.

  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