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Manager of Quality Assurance Engineering

2 months ago

Seabrook, New Hampshire, United States ARCH Global Precision company Full time
Key Responsibilities:
  • Oversee the quality assurance engineering team within a medical device production setting, ensuring that products align with client requirements and adhere to industry regulations.
  • Identify and spearhead initiatives aimed at enhancing processes to improve product quality and operational efficiency.
  • Evaluate and interpret data to foster ongoing improvement efforts and guarantee adherence to regulatory standards.
  • Direct the creation and execution of inspection protocols and testing methodologies to ensure alignment with product specifications.
  • Establish and nurture effective collaborations with cross-departmental teams, including engineering, production, and clientele.
  • Supervise and manage process validation tasks to ensure compliance with applicable regulations and standards.
  • Oversee specialized process validation tasks, including but not limited to cleaning, passivation, heat treatment, laser applications, and welding.
  • Manage supplier validation processes as necessary, and assess the suitability of current and prospective suppliers based on prior evaluations.
  • Lead the Quality Control department.
  • Formulate and manage the departmental budget, including expense management, resource forecasting, and capital equipment procurement.
  • Provide leadership, mentorship, and support to the quality engineering team.
  • Ensure that all quality-related operations are conducted in accordance with relevant standards, regulations, and legal requirements.
Qualifications:
  • A minimum of 5 to 8 years of experience in a quality engineering capacity within the medical device manufacturing sector, including at least 3 years in a managerial or leadership position.
  • A Bachelor's degree in engineering, quality assurance, or a related discipline is required.
  • In-depth knowledge of FDA and ISO regulations pertinent to medical device manufacturing is essential.
  • Experience with lean manufacturing principles and continuous improvement strategies is required.
  • Proficiency in blueprint interpretation and GD&T is preferred.
  • Exceptional leadership, communication, and organizational abilities.
  • Capability to manage multiple priorities and adhere to deadlines.
  • Strong analytical and problem-solving skills.
  • Robust project management capabilities.
  • Proficient in computer applications, particularly the Microsoft Office Suite.
Physical Requirements:
  • Light to moderate physical activity is necessary.
  • Ability to lift and carry up to 25 pounds.
  • Regularly required to stand, reach, and navigate the facility.
  • Some extended periods of sitting at a desk or computer may be necessary.
Equal Employment Opportunity Statement:

ARCH Global Precision is committed to being an Equal Opportunity Employer and actively promotes diversity in the workplace as a fundamental principle for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description does not imply that these are the only responsibilities to be performed by the employee(s) in this role. Employee(s) may be required to follow additional job-related instructions and perform other job-related duties as assigned by authorized personnel. A review of this position has excluded marginal functions that are incidental to the performance of essential job duties. All responsibilities and requirements are subject to modification to reasonably accommodate individuals with disabilities. To succeed in this role, the incumbent(s) must possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to their own health or safety or that of others. The requirements listed in this document represent the minimum levels of knowledge, skills, or abilities.