QA Compliance Supervisor

About the role

The QA Specialist is responsible for the supervision of the QA Staff and Document Control.

Responsibilities

• Provide daily supervision, leadership, and operational direction for both Quality Assurance and Document Control personnel.
• Review and approve QMS documents, SOPs, and quality records to ensure compliance with internal controls and applicable standards (e.g., FDA, GMP, ISO 13485).
• Plan, schedule, host, and lead internal and external quality audits; drive audit findings through to closure via CAPA management.
• Lead and govern the Change Control and CAPA processes, including facilitating Change Control Board (CCB) and CAPA Board meetings.
• Oversee the non-conforming material (NC) area, approve Material Review Board (MRB) disposition decisions, and perform system holds or transfers.
• Support as needed on managing the Return Merchandise Authorization (RMA) process in coordination with complaint handling, investigations, and scrap activities.
• Collaborate daily with QC Management and internal departments. Interface with internal departments, suppliers, vendors, and customers; manage customer-facing quality agreements, questionnaires, and international regulatory documentation.
• Analyze quality metrics and trends to drive root cause investigations, track Quality Objectives (KPIs), maintain scorecards, and report outcomes to management.
• Coordinate departmental readiness for Management Review meetings, including KPI compilation and reporting in support of the Management Representative.
• Care for equipment calibration schedules with external vendors and monitor metrics to ensure tool and spare instrument availability.
• Oversee quality record retention, archive monitoring, and purging; provide backup support for Document Control (e.g., CoC issuance, lot folder closure).
• Interacts with and supports the entire Quality Department in daily continuous improvement activities.
• Directly supervises 3 employees in the QA department.

Requirements

To perform this job successfully, an individual should demonstrate the following competencies:

• Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Asks for and offers help when needed.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Makes timely decisions.

Qualifications

• Education and/or Experience: Bachelor's degree (B. A.) from four-year College or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
• Knowledge: Must be experienced with Microsoft Excel Spreadsheet software and must be experienced with Microsoft Word Processing software.