Job Application: Principal Quality Engineer

Title: Principal Quality Engineer

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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Principal Quality Engineer to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

SUMMARY OF POSITION:

This position will be responsible for the leadership and management of site-level Quality-organizational personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System. The Principal Quality Engineer will be responsible for the activities associated with Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams.

ESSENTIAL FUNCTIONS:

  • This position may have direct-reporting responsibilities for daily activities of Quality personnel.
  • Designated Site-level Management Representative for assurance of compliance to the TOMZ Quality Management System.
  • Drive and support QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
  • Provide organizational Quality leadership, coaching, mentoring and guidance to all Quality personnel, as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, design transfers and sustained manufacturing customers.
  • Provide leadership and guidance for Quality functions including document control and records retention, complaint handling/returns, corrective/preventive actions, training, supplier quality management, nonconforming material handling, and metrology/calibration control systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: internal auditing, supplier quality management, complaint handling, corrective and preventive actions, nonconforming materials controls, and the tracking & reporting of associated metrics.
  • Act as champion for Quality best practices and GDP/GMP continuous improvement efforts.
  • Provide leadership and guidance for development engineering, sustained manufacturing and continuous improvement/continuation engineering activities and initiatives.
  • Provide leadership and guidance for risk management (Process FMEAs), limit characterization, inspection controls, test method development, and process validation/qualification strategies.
  • Oversee and coordinate site auditing activities (customer and regulatory agencies).
  • Ensure compliance of all site personnel to QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees, and performed in compliance with federal and local laws, as well as TOMZ policies.
  • Other duties and responsibilities as assigned.

QUALIFICATIONS:

Education

  • Minimum 4-year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

  • Minimum of 1-2 years leadership/supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 7 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

  • Advanced post-secondary education/training/certification coursework
  • Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

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