sterilucent product


Quality Manager

This individual is responsible for ensuring the quality system is implemented, maintained, and meets the intent and requirements of the applicable regulatory requirements and standards. Additionally this person serves as the Management Representative and will be responsible for providing the quality direction to support design, development, manufacturing, distribution, installation, servicing and contract services for the Sterilucent business. Responsibilities also extend to all aspects of the Sterilucent organization and all products and services developed, manufactured and/or sold by Sterilucent, Inc.


  • Establish, implement, maintain, execute, and enforce an effective quality system that complies with regulatory, national and international standards.
  • Establish, implement, maintain and manage standard operating procedures, work instructions, forms, templates and other documents that support an effective quality system.
  • Assure the execution and control of the quality system to transition new products and technologies from a development stage to an operational production/distribution stage.
  • Participate as a management team member to establish company goals and objectives supplying key elements of quality system requirements.
  • Follow, understand, and communicate to management external factors (such as customer needs, market place dynamics, competitive landscapes and regulatory and compliance trends and changes) defining their impact on quality system management as it effect business profitability, activities and decisions
  • Promote quality achievement and performance improvements throughout the organization.
  • Define quality assurance goals and objectives and implement planned quality assurance programs that accommodate and achieve corporate goals and objectives.
  • Provide expertise and guidance in interpreting regulations, agency guidelines and internal policies to assure compliance.
  • Develop relationships with professional organizations and practitioners to stay abreast with current Best Practices.
  • Identify relevant quality system training needs and deliver training.
  • Establish a system to assure corrective preventative measures are systematically implemented, monitored, and controlled.
  • Participate with cross functional teams in continuous improvement programs ensuring quality system compliance.
  • Establish quality requirements with external suppliers.
  • Ensure test and procedures are properly understood, in place and carried out.
  • Establish and implement methods to measure, monitor, track and report quality performance for internal and external products against set indicators.
  • Identify and report to management and cross functional teams, trends and variances in established quality performance that necessitates corrective/preventive action and continuous improvement to comply with standards and regulatory requirements and maintain customer satisfaction.
  • Develop an internal quality audit system to assure regulatory compliance and report non-conformances for management review.
  • Foster and maintain relationships with suppliers to ensure a compliance – oriented environment.
  • Function as the Management Representative.
  • Provide quality system leadership communicating openly with cross-functional staff and management to evaluate needs, resolve problems and obstacles, set directions, and maximize effective interactions.
  • Identify, plan and budget Quality Assurance Department resource requirements.
  • Constructively challenge and actively participate in management decision making process related to strategic and tactical business issues as they relate to quality system management and compliance.
  • Maintain corporate integrity and conduct in everyday tasks in an ethical manner as expected by senior management.
  • Maintain compliance with the quality system, environmental, health and safety policies and procedures, and responsibilities as outlined in the Sterilucent Employee Handbook.


  • BS in Chemistry, Biology, Regulatory Affairs or Engineering required.
  • Minimum 7 years’ experience in medical device quality system environment with minimum 3 years management experience.
  • Experience in establishing and maintaining a quality system compliant with 21CFR, Part 820 FDA Quality System Regulations, ISO 13485 Medical
  • Device Standard, and EU Medical Device Regulations.
  • Skilled in communicating and training all levels of the organization concepts of design control, design verification and validation, production and process controls, corrective preventative action, complaint and risk management, post market surveillance, and product quality improvements.
  • Skilled in mentoring, teaching and coaching with the ability to motivate and inspire others.
  • Skilled in developing an in-depth understanding of products and related production processes.
  • Skilled in transforming quality system strategy and methodology into specific action with clear accountability.
  • Skilled in making decisions with speed and accuracy based on best available information.
  • Skilled in acknowledging, leading, developing, communicating and implementing a strategy under crisis situations to ensure compliance.
  • Skilled in interacting with applicable regulatory agencies at the local and bureau level.
  • Skilled in external and internal auditing.
  • Skilled in handling supplier and internal audit non-compliances in a professional manner resulting in compliance resolution.
  • Skilled statistical and analytical methods.
  • Skilled in analytical quality problem solving and root cause analysis.
  • Skilled in multitasking and prioritizing competing tasks effectively.
  • Excellent oral and written communication with internal and external personnel and management.
  • Strong leadership skills and skilled in managing a quality assurance technical staff.
  • Skilled in using computer programs such as MS Word, Excel, Power Point, and Access.

Working Conditions, Physical Requirements and Equipment Use:

  • Light work, including ability to lift and move loads of up to 25 lbs. up and down a single flight of stairs..
  • Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
  • Requires fingering, repetitive motion, talking and hearing.
  • Significant work pace & pressure due to deadlines and startup company mentality.
  • Travel <25%.

See Training Matrix for training requirements of this position.

Authority and Responsibility:
In this position the employee is accountable for their performance and will have sufficient authority delegated to them to complete their tasks and meet their objectives.

Knowledge and Experience: Requires advanced knowledge in area of responsibility. Provides regular and influential specialist advice to others and raises level of expertise in the business. Researches, applies, and modifies principles and practices in a given field.
Business Interaction and Customer Focus: Work requires the ability to handle complex information. Job holder would persuade and convey ideas, impressions and information to negotiate an outcome or influence events related to a broad range of issues in area of specialty. Contacts are decision makers within area of specialty or peers in cross-functional areas, and often involve the exchange of complex/sensitive information (e.g., in negotiations). Strengthens customer relationships by taking proactive steps to improve techniques or methods for satisfying customer.
Job Complexity and Problem Solving: Job holder uses discretion to interpret policy and practice and to take independent action to varying circumstances in work area. Issues typically relate to owned functional area, but may impact other work areas. Problem solving involves gathering and evaluating the reliability of information and an understanding of the risk and impact of decisions on area. Work has a moderate degree of autonomy and job holder determines his/her own work priorities, using discretion to tailor practices to achieve results.
Leadership and Teamwork: May involve supervisory or leadership responsibility over a work group or cross-functional team to meet day-to-day operational goals or predetermined objectives. Typical skills similar to level below, but at a higher degree due to variety of issues or staff managed. As a single contributor, evaluates ideas and proposals, and examines avenues for new opportunities. Anticipates outcomes and supports others by providing expert advice and help.
Business Impact: Decisions impact the mid-range operational outcomes in one area and indirectly impacts the organization’s ability to meet profit and loss goals. May contribute to the development of the budget. Can have overall accountability to ensure established objectives are met on time and within budgeted resources (e.g., for project teams or in management of a work group.)


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