Senior Quality Engineer I

Overview

The Senior Quality Engineer is instrumental in establishing and upholding quality control measures throughout our product and process development lifecycle, and production activities to ensure manufacture of high quality and reliable products.

This role entails close collaboration with Engineering & Production teams to create and execute impactful quality assurance strategies from the initial receiving phase to the release of the final product. This role includes oversight and management of quality inspections as well as equipment calibration, qualification and maintenance.

The Senior Quality Engineer’s responsibilities fall under four main areas:

1. Management, development and validation of internal inspection processes, metrology and equipment.
2. Evaluation of inspection and measurement systems, metrology techniques, and tooling using statistical measurement system analysis methods.
3. Collaborating with cross-functional teams and suppliers to implement solutions, lead quality improvement initiatives and problem-solving efforts.
4. Management and oversight of quality inspections as well as equipment calibration and qualification.

The Senior Quality Engineer will assist in the management and implementation of the Quality Management System to ensure compliance with ISO 13485 and the FDA’s Quality Management System Regulation 21 CFR Part 820.

The Senior Quality Engineer will provide additional support to the Quality Management System’s activities as assigned at the discretion of management.

This is an on-site, full-time position.

Reports to:

Vice President of Quality Assurance & Regulatory Affairs.

Duties and Responsibilities:

The Senior Quality Engineer’s responsibilities typically involve:

• Work closely with the Engineering & Production teams to develop best practices and improve metrology and inspection techniques for product development, manufacturing processes, equipment and fixtures.
• Evaluate inspection, measurement, and test equipment, metrology techniques, and tooling to ensure suitability for intended use and compliance with quality and regulatory requirements.
• Plan, execute, and interpret Measurement System Analysis (MSA) studies, including Gage Repeatability and Reproducibility (Gage R&R), Gage Linearity, and Gage Bias studies for capability and identify sources of variation related to equipment, methods, operators, or environment.
• Collaborate with the Engineering & Production teams to establish necessary controls and verification/validation procedures for production processes.
• Develop and implement manufacturing process controls, including in-process inspections and sampling plans for receiving in-process, and final inspection.
• Responsible for supporting Engineering & Production with problem solving, process improvements and resolution to product development and manufacturability issues.
• Review Engineering drawings and changes to assure that they are properly dimensioned and conform to GD&T protocol and provide proper inspectability for the related components and assemblies.
• Evaluation of changes to design and/or manufacturing process for impact to the Design History File. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation.
• Collaborate with Engineering & Production teams to develop and maintain the risk management program for the manufacturing processes.
• Lead process validation efforts to ensure consistency and reliability in manufacturing outputs.
• Author process verification/validation protocols and reports.
• Assessing the need for new gages and equipment.
• Management of quality inspections as well as equipment calibration, qualification and maintenance.
• Support internal audits and external audits as needed.
• Lead efforts to address nonconformities and Supplier Corrective Actions relating to custom-made components.
• Participate in, or coordinate Corrective/Preventive Actions, investigations and root cause analysis.
• Additional support for the Quality Management System activities as assigned.
• On a daily basis, assess overall workload for any area that needs help, and assist coworkers and provide backup as needed without being reassigned by management.

Skills and Experience:

• Strong understanding of quality management systems and regulatory requirements in medical device manufacturing- (ISO 13485:2016, FDA 21 CFR 820).
• Experience with process validation, statistical process control, and measurement system analysis.
• Proficiency in quality tools and methodologies (e.g., Kaizen events, Lean Manufacturing, FMEA).
• Strong understanding of metrology principles and evaluation of measurement accuracy, precision, repeatability, and reproducibility, using MSA.
• Ability to apply statistical analysis to measurement data and translate results into practical manufacturing and inspection improvements.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work effectively in a cross-functional team environment.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability and resourcefulness to roll up sleeves and multitask in order to thrive in a global company environment.
• Highly organized and detailed oriented.

Education and Training:

• Bachelor’s degree in engineering, Quality Assurance, or a related field (Master’s degree preferred).
• 7+ years of experience in quality engineering, preferably in the medical device industry.
• ASQ certification (CQE, CQA, or similar), preferred.
• Experience with CAD software and GD&T principles.
• Familiarity with automation and Industry 4.0 concepts.

Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Benefits:

• 401(k) Safe Harbor Plan
• Healthcare Insurance: Medical, Dental and Vision
• Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance
• Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave
• Tuition Reimbursement Program
• Performance Bonus
• Incentive Unit Plan
• Flexible Schedule
• Lunches, Snacks, Events

Schedule:
Monday to Friday

Salary
$110,000-$150,000 per year

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