POSITION TITLE: Quality Engineer-Finished Goods
SHIFT HOURS: 8:00am to 5:00pm (days)
LOCATION: Onsite at LSI Solutions in Victor, NY
SALARY PAY RANGE:Tier I ANNUAL SALARY: $66,500 minimum; $91,500 maximum, based on experience.Tier II ANNUAL SALARY: $68,500 minimum; $103,300 maximum, based on experience.Senior ANNUAL SALARY: $75,500 minimum; $113,600 maximum, based on experience.
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
ESSENTIAL FUNCTIONS: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.
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.
Design:
- Generate and maintain risk documentation, including, but not limited to Hazard Assessments, Risk Assessments, and Risk Reports, and be a strong contributing team member to Failure Mode and Effects Analyses (FMEA's).
- Create statistically rationalized component and product acceptance inspection plans.
- Analyze data using tools such as Capability Analyses/Studies, SPC, and trend analyses to update inspection plans and control plans.
- Apply Design Controls Management knowledge to product design and gate reviews, as well as Design History File (DHF) updates, by reviewing and approving technical documentation such as project charters, drawings, and validation/verification protocols, reports, and records.
- Review and approve New Product Development project deliverables, as well as product enhancement project deliverables, for compliance, completeness, and consistency, with a focus on "Design for Quality."
Metrology:
- Assist in development of gauges and fixtures.
- Support & participate in Process Flow Diagram (PFD), Process Failure Mode and Effects Analysis (PFMEA), & Process Control Plan (PCP) team meetings.
- Review and approve inspection plan measurement methods for components.
- Coordinate and track component Measurement Systems Analysis (i.e. GR&R, etc.) activities.
- Assist manufacturing with implementation, maintaining and training of statistical tools.
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.
ADDITIONAL RESPONSIBLITIES:- All other duties as assigned.
EDUCATION & EXPERIENCE: 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.
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.
Design:
- A strong working knowledge of ISO 14971.
- A working knowledge of Design Controls Management practices and procedures (Design & Development Planning, Design Input, Design Output, Design Review, Design Verification & Validation, Design Transfer, Design Changes, and Design History File).
- Demonstrated application of statistical tools and techniques.
- Experience with Minitab preferred.
- Knowledge of external standards and regulations pertaining to medical devices, specifically the European Medical Device Regulation (EU MDR), and Biocompatibility and Usability standards is preferred.
Metrology:
- A strong working knowledge of Metrology and measurement equipment.
- Experienced in developing Gauges and Fixtures.
- Experience in performing MSA of metrology equipment, gauges and fixtures (i.e. Gage R&R).
- Knowledge and application of ISO 10012, ASME Y14.5 Dimensioning & Tolerancing.
Finished Goods:
- 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.
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).
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
