Software Quality Assurance Analyst - Rochester, NY

Long term contract - $40/hr to $50/hr

The Software Quality Assurance Analyst will conduct verification and

validation activities for the Shop Floor Information Systems and other

computer systems for use in the manufacturing and release of Medical

Device products (Contact Lenses) on a project bases and/or process basis.

Software Quality Assurance Analyst for Contact Lens manufacturing

platform in the Rochester facility.

Must possess excellent written and verbal communication skills and be able

to guide others to make sound Quality decisions. The SQA Analyst must be

self-directed and must show initiative in identifying and resolving

opportunities for improvement, promoting Quality initiatives.

KEY ACTIVITIES / RESPONSIBILITIES

-Review & approval of test scripts and plans in regard to suitability to

proceed with validation activities.

-Development of protocols, test scripts and associated support

documentation, where appropriate.

-Oversight of and participation in the execution of software related

protocols.

-Conduct Root Cause Analysis and participate in debugging activities.

-Responsible for participation in the Corrective Action process in regard to

individual validations to ensure follow-up and effective resolution.

-Provide feedback to the validation strategies to improve data integrity, data

verification and software change control.

-Responsible for driving toward new state-of-the-art systems and

technologies in support of digitization of manufacturing data inputs and

outputs.

-Follow local and regional Standard Operating Procedures while carrying

out duties.

-Participate fully in all GMP and operational training programs and

complete all training records in an accurate manner.

• Ensure compliance to B+L global and plant quality system elements.

• Other projects as required.

SCOPE OF POSITION

The SQA Analyst will act as a contributor on software or automation projects, conduct verification and validation activities for Shop Floor Information Systems and other computerized systems for use in the manufacturing and release of Medical Devices on a project basis. The SQA Analyst plays a key role in meeting challenges faced within critical projects and manufacturing operations. Functions independently and as part of a team within Rochester Manufacturing Operations. Must be self-directed, be able to identify requirements and establish procedures and specific objectives. Expected to coordinate work activities, providing direction and support to peers and others. Provides leadership by coordinating work activities, administrative tasks, and advising others. Minimal travel as required.

KEY RELATIONSHIPS

This position must be able to liaise between internal business partners across varying functions. These functions include other members of plant quality, manufacturing, IT, engineering, logistics, supply chain, and R&D. This position must be able to interact with external auditors.

QUALIFICATIONS/ TRAINING

Bachelor's degree in science or related field required. Computer Science Degree preferred.

OR

Minimum 10 years of relevant experience in Quality, IT or Engineering.

-Demonstrated ability to execute software validation and change control activities.

-Knowledge of ISO 13485, FDA 21CFR parts 11, 820 requirements in addition to system development and management in medical device industry.

-Computer experience with MS Office Suite and database type software.

-Demonstrated project management and leadership skills.

-Strong written, oral and interpersonal skills.

-Ability to work in team environment.

-Ability to manage varied workload and prioritize effectively.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.