JOB DESCRIPTION
POSITION: Quality Control & Regulatory Compliance Manager
SUMMARY
Results-driven professional with a robust background in ensuring quality assurance and compliance with ISO, FDA, UL, ITAR, and safety standards. Proficient in guiding all facets of quality management to guarantee products meet customer specifications and regulatory requirements. Experienced in developing and aligning quality assurance objectives with corporate strategies and effectively communicating these principles to key stakeholders.
Our client is a leader in the design, development, and short run manufacturing, serving a wide variety of clients, many of whom are in the medical device area. You will operate in a highly collaborative and empowered work environment and will be called upon to occasionally roll up your sleeves to pitch in to help in other areas.
KEY RESPONSIBILITIES
· Develop, align, and uphold quality assurance objectives in line with corporate strategies.
· Implement and manage the company's Quality Management System, ensuring its efficiency and compliance.
· Rigorously review quality assurance data to ensure conformity with company policies and procedures.
· Innovate problem-solving strategies to address quality issues and drive process enhancements.
· Design and execute comprehensive quality assurance training programs for personnel in collaboration with managers.
· Investigate and resolve customer complaints related to product quality in a timely and effective manner.
· Apply statistical process control methods for data analysis and process validation.
· Lead various quality-related activities including validations, PPAPs, Gage R&Rs, and Capability Studies.
· Spearhead projects aimed at enhancing quality systems, such as developing procedures for reporting, analysis, and resolution of material non-conformance indices.
· Conduct thorough root cause analysis to address audit findings, product complaints, and safety issues promptly.
· Prepare and deliver technical presentations to the management team to facilitate informed decision-making.
· Actively participate in quality management teams to drive organizational excellence and continuous improvement.
SUPERVISORY RESPONSIBILITIES
Provide overall direction, coordination, and evaluation of the department's activities. Supervise employees, including interviewing, training, performance appraisal, and conflict resolution, in adherence to organizational policies and applicable laws.
QUALIFICATIONS
· Bachelor’s degree in engineering preferred.
· Minimum five years of related experience or equivalent combination of education and experience.
· Experience with ISO 13485 and medical devices.
· Proficiency in manufacturing, engineering, or technology fields.
· Strong verbal and written communication skills.
· Proficiency in utilizing Manufacturing Software (e.g., ERP/MRP, MES), CAD Software (e.g., Solidview, Solidworks), and Microsoft Office suite (including Outlook, Excel, and Word) to support quality assurance and compliance efforts.
COMPETENCIES
· Problem-solving
· Technical skills
· Interpersonal skills
· Oral and written communication
· Teamwork
· Quality management
· Ethics
· Judgment
· Motivation
· Safety and security
· Professionalism
· Continuous Improvement
· Analytical Thinking
· Leadership
· Strategic Planning
· Attention to Detail
REASONING ABILITY
Ability to analyze complex situations and devise effective solutions. Capacity to think critically and make informed decisions to address challenges.
COMPENSATION AND BENEFITS
· Full-time position with competitive salary compensation and bonus.
· Comprehensive Health & Dental Insurance coverage.
· Generous holidays, sick time, and Paid Time Off (PTO) benefits.
· 401K retirement plan with employer match.
· Flexible work schedule options to accommodate work-life balance needs.
MUST BE A US CITIZEN AS DEFINED BY ITAR.