Quality Engineering Director

VulcanForms

VulcanForms

Quality Assurance
Devens, MA, USA
Posted on Monday, May 29, 2023

About us

VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal additive manufacturing (AM) solution and pioneered integrated digital production systems. We are a team of leading technology and operational experts with decades of experience in advanced manufacturing, materials, automation, and robotics. We continuously seek contributors who demonstrate outstanding integrity, intelligence, accountability, and a passion for learning. We celebrate diversity and are committed to creating an inclusive environment for all employees.

VulcanForms Inc. seeks a Director of Quality Engineering onsite position for our Devens, MA, location.

Job Purpose

VulcanForms is seeking a Director of Quality Engineering that is an experienced expert in operating in facilities that are ISO certified. The Director of Quality Engineering will lead the quality team in developing and executing Quality operations in-line with VulcanForms' mission and vision. The Director will implement and monitor all company quality systems to demonstrate compliance with all regulatory requirements, including ISO 13485. This position is responsible for providing quality guidance for design, development, and manufacturing strategies related to the production of parts for multiple industries, including medical.

The Director of Quality Engineering must have knowledge of quality systems and compliance to support systems, software, and service. This position is accountable for ensuring all supplier management, manufacturing, new product development, quality control testing, and shipping activities are conducted according to prescribed procedures, policies, and regulations and for leading, managing, and coaching the Quality team. The successful candidate will be a hands-on self-starter with the ability to collaborate and work closely with various teams and functions, including manufacturing, supply chain, finance, facilities, process development, and regulatory procedures to ensure quality GMP standards, compliance with global regulations, and support of regulatory filings and audits.

Key Accountabilities

  • Evaluate production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
  • Assure that all facilities are compliant with ISO 9001 and ISO 13485, and AS9100 for all facilities.
  • Manage compliance with the IQ, OQ, PQ process and ensure quality information is recorded correctly.
  • Develop an internal audit program that meets every section of the ISO requirements in all facilities.
  • Manage the specifications and forms on the company intranet site.
  • Assure all quality inspectors are professionally trained and evaluated.
  • Assure that the stamp compliance program is compliant and controlled.
  • Collaborate with management and senior staff across production departments and roles to draft acceptable quality standards.
  • Implement an Operator Quality Certification program.
  • Develop and implement quality standard testing and evaluation processes.
  • Facilitate communication among production divisions and management.
  • Assess test results and approve recommended changes.
  • Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
  • Conduct random inspections and quality control checks.
  • Periodically report the status of quality control and operations to executive leadership and, when required, regulatory agencies.
  • Assure that KPIs are in place, measured, and successful.
  • Update and create additional reports and post the results in both facilities.
  • Issue Corrective Action Requests and ensure root cause analysis is complete and in place for all quality and operational deficiencies.
  • Performs other related duties as assigned.

Qualifications

  • Eight to 10 years of related experience required, with at least five years as a Quality Manager or similar role highly preferred
  • Experienced in aerospace, commercial, and medical products
  • Knowledge of FDA and FAA regulations, audits, and system implementation
  • Expert knowledge of medical quality systems and FDA regulations
  • Prior experience qualifying medical products to quality requirements
  • Excellent Team Leadership skills
  • Strong supervisory and leadership skills and ability to hold people accountable to goals
  • Ability to supervise, lead, manage, and motivate reports
  • Thorough understanding of quality control standards and methodologies
  • Thorough understanding of manufacturing and production standards across multiple industries
  • Expert knowledge of ISO and AS certification standards
  • Understanding and knowledge of the IQ, OQ, PQ process
  • Proficient with Microsoft Office Suite or related software
  • Knowledge of gage calibration systems
  • Knowledge of Mil standards and sampling procedures
  • Ability to interpret engineering drawings and determine inspection methods
  • Oversee and manage a robust internal and supplier audit system

Preferred

  • Knowledge of aerospace requirements
  • Excellent verbal and written communication skills
  • Strong sense of ownership
  • Excited about taking on new challenges in the metal additive manufacturing industry and working in a fast-paced startup environment
  • Self-motivated, hands-on, with a practical mindset, and capable of setting and reaching ambitious goals

Benefits

  • Medical, dental, vision, and life insurance are available to you starting on your first day of employment
  • Generous time off package, including vacation PTO, sick PTO, and company-paid federal holidays
  • 401(k) with company match and stock options