Quality Assurance Specialist

Praxis Technology•Queensbury, NY

7d•Onsite

About The Position

Are you ready to work for a company that truly cares about making a meaningful difference in this world? Culture Join a team that makes innovations reality, owns the process and demands excellence all while supporting your work-life balance with flexible schedules, ample vacation time to rest and recharge, and a relaxed atmosphere so you can focus on what matters — doing good work that makes people’s lives better. We value people that are highly motivated, self-starters open to learning new things every day. We’re looking for people with a good attitude and strong character who strive to be the best at what they do, take accountability for their actions and are determined and committed to get the job done. We’re highly collaborative, innovative thinkers and we need people from diverse backgrounds and levels of experience to join our growing team. We’ve built our workplace on inclusivity treating everyone with respect and integrity and providing people with the support and space to do their best work. Benefits We’re a company that values you and your career path and recognizes the importance of work-life balance. In addition to being part of a locally owned and operated business who values treating everyone with integrity and respect, we offer the following benefits to our employees: Employee and/or Employee + Child(ren) medical insurance costs you just $1/month! Comprehensive Dental + Vision 401k Retirement Plan that we match up to 3% Basic Life AD&D Insurance Employee Assistance Program Paid time off — 18 days first year (pro-rated) Paid holidays — 9 days Annual Performance Bonus Potential Employee Profit Sharing Tuition Assistance Shift differential: 2nd shift – + $1/hr, 3rd shift – + $3/hr We pride ourselves on being a community-minded company that provides lots of opportunity to learn, grow and be at your best every day. Position Summary Reporting to Quality Manager, the Quality Assurance Specialists plays a crucial role in ensuring the production of high-quality products while maintaining and improving our quality management systems to meet regulatory requirements. The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive attitude, and strong commitment to quality. How You’ll Make an Impact Perform root cause investigations of non-conformities and customer complaints; implementing corrective and preventative actions to prevent recurrence. Support Corrective and Preventive Actions (CAPA) to continuously improve the quality management system. Maintain the computerized maintenance management system by entering new equipment and equipment changes. Support the calibration program by ensuring timely completion calibrations. Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods. Lead and participate in the development and implementation of quality systems, records, and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies. Support internal audits to assess the effectiveness of the quality management systems. Conduct regular inspections and audits to identify defects, deviations, or non-compliance issues. Provide training and support to employees to ensure adherence to quality standards. Support external audits from regulatory bodies and customers. Identify, champion and support continuous improvement projects in quality, productivity, and/or safety. Maintain and trend quality metrics. Perform lot history record review, releasing manufacturing lots and issuing certificates of conformance to customers. Serve as a subject matter expert in quality assurance on cross-functional teams ensuring compliance to the compliance with applicable regulatory requirements, standards, and company policies.

Requirements

Minimum three (2) years experience working in a Quality Department in a manufacturing environment.
Strong analytical and problem-solving skills
Familiarity with quality management systems and tools
Detail-oriented with a focus on continuous improvement
Excellent interpersonal skills, with ability to collaborate with and support all levels of associates
Demonstrated ability to assess priority, complete tasks, and work independently
Demonstrated verbal and written communication skills, organized and effective technical writing
Working knowledge of ISO 13485, QSR, GMP, AS9100 (preferred)

Nice To Haves

Experience within Medical Device, Aerospace Industry, or other regulated industries preferred.
Experience in writing production, quality and safety procedures and/or qualification protocols and documents ( preferred )

Responsibilities

Perform root cause investigations of non-conformities and customer complaints; implementing corrective and preventative actions to prevent recurrence.
Support Corrective and Preventive Actions (CAPA) to continuously improve the quality management system.
Maintain the computerized maintenance management system by entering new equipment and equipment changes.
Support the calibration program by ensuring timely completion calibrations.
Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods.
Lead and participate in the development and implementation of quality systems, records, and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies.
Support internal audits to assess the effectiveness of the quality management systems.
Conduct regular inspections and audits to identify defects, deviations, or non-compliance issues.
Provide training and support to employees to ensure adherence to quality standards.
Support external audits from regulatory bodies and customers.
Identify, champion and support continuous improvement projects in quality, productivity, and/or safety.
Maintain and trend quality metrics.
Perform lot history record review, releasing manufacturing lots and issuing certificates of conformance to customers.
Serve as a subject matter expert in quality assurance on cross-functional teams ensuring compliance to the compliance with applicable regulatory requirements, standards, and company policies.

Benefits

Employee and/or Employee + Child(ren) medical insurance costs you just $1/month!
Comprehensive Dental + Vision
401k Retirement Plan that we match up to 3%
Basic Life AD&D Insurance
Employee Assistance Program
Paid time off — 18 days first year (pro-rated)
Paid holidays — 9 days
Annual Performance Bonus Potential
Employee Profit Sharing
Tuition Assistance
Shift differential: 2nd shift – + $1/hr, 3rd shift – + $3/hr