Quality Sr Specialist

The Quality Engineer serves as the process owner and technical leader for assigned Quality Engineering processes, ensuring effective implementation, compliance, and continuous improvement. The role provides Quality Engineering leadership across manufacturing and quality activities, including NCMR, CAPA,, calibration and preventive maintenance, and process improvement.

Lead and/or oversee NCMR and CAPA processes, ensuring thorough and scientific based investigations identify the true root cause rather than a proximate cause, along with risk-based impact assessments, effective corrective actions, effectiveness checks, and timely closure.

Analyze quality metrics and trends to identify recurring issues, potential product and process risks, and opportunities for preventive action and continuous improvement. Use risk-based approaches to prioritize quality issues and determine appropriate actions.

Own and maintain the Equipment Calibration and Preventive Maintenance Program, ensuring equipment is properly calibrated, maintained, documented, and suitable for its intended use based on applicable quality and risk requirements.

Lead or support evaluation of out-of-specifications calibration results and equipment failures, including risk-based assessment of potential impact on product quality, processes, and previously accepted product, and initiation of appropriate quality actions.

Support the Sterilization Quality Assurance Program, including process monitoring, quality reviews, investigations, risk-based evaluation of sterilization-related issues, and annual sterilization quality review activities.

Lead and/or participate in internal and external audits, including preparation, execution, response to findings, risk-based evaluation of audit observations, and corrective action follow-up.

Identify and address quality system and compliance gaps, assessing associated risks and driving appropriate corrective and preventive actions.

Develop, review, and improve quality procedures, SOPs, Work Instructions, specifications, and other controlled documents within assigned processes.

Support regulatory and quality initiatives and promote a strong quality culture, risk-based decision-making, compliance mindset, and proactive problem-solving approach.

Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).

Ability to deliver, meet deadlines and have results orientation.

Able to communicate both orally and in written form to multiple levels of the company.

Demonstrates characteristics of high potential for future development opportunities.

Microsoft Office Suite

Knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and can use optical comparators and CMMs.

Strong process ownership and leadership skills

Highly detail-oriented and organized

Strong analytical and critical-thinking skills

Ability to analyze data, identify trends, and make risk-based decisions

Strong follow-through, accountability, and time-management skills

B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).

2-4 years of work experience.

Certified Quality Engineer (CQE) and Medical device is a plus

Combination of education and experience may be considered (in evaluating experience relative to requirements)

Experience with NCMR, CAPA, root cause analysis, risk management, change control, audits, product release, and continuous improvement.

Experience managing or supporting equipment calibration and preventive maintenance programs

Up to 15%

Salary Expectations:

$100,000-$125,000

EOE/M/F/Vet/Disability