Total Quality Management Senior Manager jobs in Schenectady, NY

Are you ready to work for a company that truly cares about making a meaningful difference in this world?

A little about us:

Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets.We create sustainable flexibility that delivers maximum impact to make people’s lives better. It's pretty cool stuff!

We value people that are highly motivated, self-starters, open to learning new things every day. We look for like-minded individuals who will embrace the five core values of Praxis:

• Team player
• Driven to improve
• Genuinely care
• Dependable
• Own

What we can offer you:

In addition to being part of a locally owned & operated business who values treating everyone with integrity & respect, we offer the following benefits to our full-time employees:

• Employee and/or Employee Child(ren) medical insurance for 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

Position Summary

Reporting to Quality Manager, the Senior Quality Engineer plays a crucial role in ensuring the production of high-quality products while maintaining and improving our quality management systems to meet regulatory req  The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive attitude, and strong leader in 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.
• Lead and facilitate Corrective and Preventive Actions (CAPA) to continuously improve the quality management system.
• Manage the calibration program by ensuring proper calibration requirements for new equipment and gages, timely completion, and assessing the impact of out-of-tolerance events.

• Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods.
• Maintain supplier quality, issuing supplier corrective action requests and leading supplier audits.

• Participate in risk management activities to identify and mitigate potential process and quality risks.
• 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 validation and qualification of new equipment and processes ensuring it meets industry standards and regulatory requirements.
• Conduct measurement systems analysis (Gage R&R, Attribute Agreement Analysis, etc.) to ensure capability of measurement and test methods.
• Conduct internal audits to assess the effectiveness of the quality management systems.
• Support external audits from regulatory bodies and customers.

• Identify, champion and support continuous improvement projects in quality, productivity, and/or safety.

• 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.
• Mentor and help support the development of the quality engineering and quality assurance team.

What You Must Bring to This Role

• Minimum seven (7) years experience working in a Quality Department in a manufacturing environment.
  • Experience within Medical Device, Aerospace Industry, or other regulated industries.
• Working knowledge of measurement techniques, root cause analysis, corrective and preventative action
• Experience in writing production, quality and safety procedures and/or qualification protocols and documents

• Experience in supplier quality control

• Experience supporting Internal and/or external audits
• Working knowledge of statistical techniques, and data
• Working knowledge of ISO 13485, QSR, GMP
• 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
• Bachelor’s degree in engineering or a related field (preferred)
• Working knowledge of AS9100 (preferred)

Working Conditions & Physical Efforts

• Work is performed in a Production environment
• May be required to lift up to 50 lbs.
• Ability to stand or sit for a prolonged period of time
• Visual functions being those of acceptable or corrected near vision, depth perception, and ability to adjust focus
• Talking and hearing occur continuously in the process of communicating with associates, leadership & suppliers
• Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard or operate equipment
• Moderate exposure to physical risk

Praxis is an equal opportunity employer