Quality Analyst I

Lsi Solutions; Town of Victor (NY); On-site; USD 29,000 - 48,000; Full time

Benefits offered by this job

Bonus plan

401(k) match

Tuition assistance

Employee Assistance Program (EAP)

Product discounts

15 paid holidays

PTO

Medical insurance

Vision

Dental

Job summary

LSI SOLUTIONS® in Victor, NY is seeking Quality Analysts I–III to join our sterile, regulated manufacturing environment. You will perform quality control inspections, line audits, and documentation reviews across multiple product families, escalating nonconformances as needed.

Level I–III responsibilities span paperwork, ERP transactions, GAS system use, and continuous improvement participation. This is an onsite role with evening shifts and a $2.00/hour differential.

Qualifications

• Associate degree in a technical discipline preferred.
• High School Diploma or equivalent and 2 years of regulated manufacturing experience acceptable in lieu of Associate degree.
• ASQ CQPA or CQACertification preferred.
• Familiarity with GMPs, Quality Standards, and Regulatory Compliance is highly desired.
• Quality Control Inspection, Line Audit and Documentation Review preferred

Responsibilities

• Level I: Process paperwork, cleanroom work, maintain quality, review records, locate documents in GAS, perform all steps within 2 product families, transact materials in ERP, inspect and audit material status, enforce good documentation practices, originate nonconformance reports, segregate non-conforming product.
• Level II: Perform Level I tasks with supervision, support Cleanroom and QMS, create metrics reports, maintain databases, develop standard work instructions, assist in audits, suggest improvements, participate in CI teams, support project completion, perform PM activities.
• Level III: Coordinate nonconformance reports, supervise staff, train and coach employees.

Skills

Communication

Attention to detail

MS Excel

ERP systems

Teamwork

Education

Associate degree

High School Diploma or equivalent

ASQ CQPA or CQACertification

Tools

GAS / Grand Avenue Software

ERP systems

Job description

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 joiningLSI 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 Analyst I, II, III

LOCATION:

Onsite at LSI Solutions in Victor, NY

HOURLY PAY RANGE:

Plus a Shift Differential of $2.00/hour

Tier I HOURLY RATE: $21.00/hour minimum; $28.75/hour maximum, based on experience

Tier II HOURLY RATE: $23.00/hour minimum; $31.50/hour maximum, based on experience

Tier III HOURLY RATE: $23.00/hour minimum; $34.75/hour maximum, based on experience

SHIFT HOURS:

(Evenings 2:30pm to 11:00pm)

LOCATION:

Onsite at LSI Solutions in Victor, NY

ESSENTIAL FUNCTIONS: (Quality Control Inspection, Line Audit and Documentation Review preferred)

Level I

• Process paperwork accurately and neatly.
• Work in Cleanroom Environment.
• Maintain consistent quality and workmanship.
• Conduct detailed records review.
• Search and locate documents in Grand Avenue Software (GAS).
• Perform all process steps within 2 product families.
• Properly transact materials in ERP system.
• Conduct inspection and in-process audit of material status throughout product realization.
• Ensure enforcement of good documentation practices within Device History Records.
• Originate Nonconformance reports.
• Segregate and control non-conforming product.

Level II

• Perform Level I functions efficiently and effectively without continuous supervision.
• Understand and support Cleanroom and Quality System processes.
• Participate in the creation of metrics reports with Quality Engineers.
• Maintain databases to support metrics reporting.
• Participate in developing standard work instructions.
• Assist in internal audits, as necessary.
• Suggest process and system continuous improvements.
• Participate in Continuous Improvement Teams.
• Support Quality Engineers in project completion.
• Perform PM activities (i.e. bioburden, environmental monitoring).

Level III

• Coordinate Nonconformance reports.
• Assist in supervision of staff and monitoring productivity.
• Assist in training of new employees and coaching existing employees.
• Assist team members. Be helpful and encouraging.

ADDITIONAL RESPONSIBILITIES:

• All other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

Level I:

• Excellent verbal and written communication skills with various levels of management and coworkers.
• Demonstrated ability to follow instructions, both written and verbal.
• Able to communicate effectively with cross-functional teams in a manner that supports internal and external customers alike.
• Ability to exercise independent judgement as well as work alongside team members.
• Demonstrated proficiency using Microsoft Office applications including Excel.
• Working knowledge of ERP systems and other electronic databases.
• Maintain good and cooperative relationships with colleagues involved in other aspects of the process or operations in order to promote strong teamwork.
• Attention to detail, technical aptitude, and process-oriented troubleshooting skills necessary.

Level II:

• Able to create metrics, maintain databases, analyze and recognize trends and inconsistencies.
• Experience with continuous improvement efforts of systems and processes.
• Familiarity assisting with quality audits.

Level III:

• Demonstrated ability to assist in the supervision, training, and coaching of others.

EDUCATION & EXPERIENCE:

• Associate degree in a technical discipline preferred.
• High School Diploma or equivalent and 2 years of demonstrated success in a highly regulated manufacturing environment acceptable in lieu of Associate degree.
• ASQ CQPA or CQACertification preferred.
• Familiarity with GMPs, Quality Standards, and Regulatory Compliance is highly desired.
• Quality Control Inspection, Line Audit and Documentation Review preferred

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.

• Sitting, standing and/or walking for up to eight hours per day.
• Frequently required to lift and/or carry up to 40 lbs.
• Regularly required to talk and/or hear, see, see color, perform repetitive motion and reach.

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

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

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