Quality Assurance Manager

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 Assurance Manager

SHIFT HOURS: Monday - Friday 8:00am - 5:00pm

LOCATION: Onsite at LSI Solutions in Victor, NY

SALARY PAY RANGE:  $83,000 minimum; $125,000 maximum, based on experience.

JOB SUMMARY: The Quality Assurance Manager is responsible for ensuring full standards compliance, leading LSI’s CAPA function, implementing internal audit programs to ensure QMS compliance and efficiency, and providing vision, guidance, and validated solutions for quality information systems which meet cross-functionally identified LSI business needs. 

REPORTS TO: Quality Director

SUPERVISES: Yes

ESSENTIAL FUNCTIONS:

• Leads and manages the Quality Assurance department by recruiting, selecting, training, and mentoring employees.
• Establishes a deep understanding of LSI’s Quality Management System: how it is organized; how its components map to ISO 13485, FDA QMSR, EU MDR, and MDSAP requirements; how the various QMS processes link and work together; and how the documentation (both electronic and paper-based) is collected, managed, and stored. This includes “walking” the processes and building first-hand knowledge of how the system really works. Maintain regulatory compliance of the quality management system, through:
  

• Managing the gap assessment process for all new or revised standards and common specifications,
• Participating in the gap assessment process for new or revised regulations in collaboration with the Regulatory Team. 
• Ensuring an effective review of all changes and updates to Quality Management System SOPs to ensure continued compliance to standards and regulations; and
• Leading compliance improvement initiatives, including identifying and implementing targeted initiatives to improve QMS efficiency and effectiveness while maintaining full compliance.
  

• Manages and provides guidance and oversight to a team of one or more internal auditors, ensuring the internal audit team develops and is trained to appropriate internal auditor training profiles. Also works with the internal audit team to develop an appropriate internal audit schedule. Serves as an internal auditor to supplement the internal audit team as needed.
  

• Leads LSI’s CAPA function, ensuring CAPAs are awarded the appropriate resources to be completed effectively and timely. Develops CAPA and Root Cause Analysis expertise throughout LSI, and monitors and evaluates CAPA processes and procedures for continuous improvement opportunities through maintenance and development of metrics.
• Identifies and submits high-value-add CAPA requests based on knowledge of the QMS, observations from “walking” the system, and various audits. 
• Participates on and leads CAPA projects as assigned, effectively applying problem-solving techniques to clearly identify and remedy root cause to develop persistent solutions. 
• Mentors quality engineers on the Quality Assurance Team to ensure they are effective participants in LSI’s CAPA program.

• Develops and updates processes and documentation as necessary to support the quality system.
• Guides LSI’s Quality Information Systems function, ensuring appropriate, effective, and compliant control of records and document control systems are employed; quality system processes and software are identified, validated, and implemented to support efficient design and development processes/DHF capture and maintenance, the ability to efficiently and effectively access and analyze quality data, and the ability to efficiently and effectively capture and process customer complaints, NCMRs, and customer feedback.
• Develops and maintains quality objectives metrics and leads cross-functional monthly quality objectives meetings for senior leadership and responsible parties to develop and drive action plans to ensure performance relative to the quality objectives.
• Identifies and partners effectively with all internal customers to ensure that our quality system is robust and efficient.
• Maintains annual qFMEA for LSI’s Quality Management System.
• Maintains staff by appraising, encouraging, and counseling employees; and recruiting and training to fill skill gaps and sustain planned business growth.

ADDITIONAL RESPONSIBILITIES:

• Ensures compliance with company policies and procedures.
• Ensures teams function in a safe manner and are aware of safety rules & regulations.
• Manages and reports on departmental projects via project Focus Maps.
• Conducts departmental performance reviews; develops succession plans, personnel development and growth initiatives, work improvement plans, and disciplinary actions when warranted.
• Promotes and demonstrates customer service mentality via inter-departmental relations and support.
• All other duties as assigned.
• Develops and reports Quality System metrics for management.

EDUCATION & EXPERIENCE:

• 4 years of experience in Quality Assurance or Quality Control at a medical device company where an ISO 13485 Quality Management System has been employed. 
• Bachelor’s degree in a technical discipline. 
• Leadership experience in a Quality Assurance or Quality Control role is preferred.
• ASQ Certified Manager of Quality is preferred.

KNOWLEDGE, SKILLS & ABILITIES:

• Proficient with medical device regulations, e.g., FDA 21CFR820, ISO 13485, CMDR and MDD/MDR.
• Proficient with core Quality skills, e.g., internal auditing, statistical analysis techniques, problem-solving and root cause analysis, and Cost of Quality concepts.
• Excellent communication skills (verbal and written).
• Excellent computer skills.
• Ability to lead cross-functional teams.
• Team oriented facilitator/mentor/worker.
• Customer-focused, goal-oriented self-starter.
• Familiar with process control and capability analysis, measurement tools, acceptance sampling techniques, and supplier management.
• Familiar with electronic systems implementation and management, including FDA 21CFR11.

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.
• Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• Regularly required to talk and/or hear, see, handle, reach.
• Occasionally required to see color.

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

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