The QA Specialist is responsible for the supervision of the QA Staff and Document Control. Essential Duties and Responsibilities include the following. Other duties may be assigned.

Department Leadership :

Provide daily supervision, leadership, and operational direction for both Quality Assurance and Document Control personnel.

Quality System Oversight :

Review and approve QMS documents, SOPs, and quality records to ensure compliance with internal controls and applicable standards (e.g., FDA, GMP, ISO 13485).

Audit Leadership :

Plan, schedule, host, and lead internal and external quality audits; drive audit findings through to closure via CAPA management.

Governance & Meetings :

Lead and govern the Change Control and CAPA processes, including facilitating Change Control Board (CCB) and CAPA Board meetings.

Material Compliance :

Review and approve material compliance declarations (e.g., REACH, RoHS, Prop 65) and provide technical/regulatory support as needed.

Training & Onboarding:

Develop, conduct, and maintain site-wide GMP and quality system training programs for personnel.

Non-Conforming Material & MRB :

Oversee the non-conforming material (NC) area, approve Material Review Board (MRB) disposition decisions, and perform system holds or transfers.

RMA & Complaint Support :

Support as needed on managing the Return Merchandise Authorization (RMA) process in coordination with complaint handling, investigations, and scrap activities.

Cross-Functional & Customer Support :

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.

Quality Metrics & Analysis :

Analyze quality metrics and trends to drive root cause investigations, track Quality Objectives (KPIs), maintain scorecards, and report outcomes to management.

Management Review Support :

Coordinate departmental readiness for Management Review meetings, including KPI compilation and reporting in support of the Management Representative.

Calibration Management :

Coordinate equipment calibration schedules with external vendors and monitor metrics to ensure tool and spare instrument availability.

Document Control & Retention :

Oversee quality record retention, archive monitoring, and purging; provide backup support for Document Control (e.g., CoC issuance, lot folder closure).

General Support :

Interacts with and supports the entire Quality Department in daily continuous improvement activities. Supervisory Responsibilities Directly supervises 3 employees in the QA department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Competencies To perform the 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; Benefits organization through outside activities; Supports affirmative action and respects diversity. 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. Completes tasks on time or notifies appropriate person with an alternate plan. 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 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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. Language Skills Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Mathematical Skills Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have knowledge of Must be experienced with Microsoft Excel Spreadsheet software and must be experienced with Microsoft Word Processing software. Certificates, Licenses, Registrations

ISO 13485

2016 trained auditor or certified auditor (plus / preferred) Other Skills and Abilities Ability to read and interpret blueprints, including geometrical dimensioning and tolerancing, and quality instructions. Working knowledge of material compliance regulations (e.g., REACH, RoHS, Prop 65). Other Qualifications Strong understanding and application of statistical concepts and process control techniques. Demonstrated ability to collaborate effectively across cross-functional teams in a fast-paced manufacturing environment. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to sit; reach with hands and arms and climb or balance. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision and depth perception. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.