Sr CAPA Specialist

Exactech, Inc.
Job Description

Job Details

Description

 

Duties and Responsibilities (Key Deliverables):

Develop and coordinate the company’s Corrective and Preventive Action (CAPA) process to ensure regulatory compliance and effectiveness.
• Define and document CAPA requirements and design forms to include required elements to ensure successful BSI and FDA audits/investigations.
• Collaborate with Quality Project Team Leaders on suggestions and planned changes to the CAPA process.
• Train new CAPA Project Team Leaders.
• Assess CAPA plan for acceptance/rejection providing direction to CAPA Project Team leaders to ensure action items are complete and appropriate to provide a successful effectiveness check.
• Process request for changes to plan.
• Evaluate CAPA objective evidence for applicability/acceptability including reconciliation of product.
• Evaluate CAPA closure requests, prepare for closure ensuring nonconformance has been satisfied and CAPA effectiveness checks are adequately documented.
• Collaborate cross-functionally with various teams to effect resourceful conclusions to issues arising from the closure review.
• Review CAPA closure with CAPA Project Team Leaders and obtain required signatures; sign the closure request confirming acceptability.
• Compile statistical data and monthly charts/reports to provide detailed tracking of status of all open CAPAs; Monthly Escalation Reports; etc.
• Compile statistical data to create annual trending charts reflecting the status of the CAPA system.
• Create and maintain working and protected electronic directories.
1. Assist Regulatory Affairs with product correction and removals (recalls, market withdrawals and stock retrievals) to ensure compliance with CAPA related activities.
2. Providing training to employees, sales agents, sales representatives and customers regarding the regulatory requirements for corrective and preventive actions.
3. Ensuring company procedures and documentation meet the required guidelines for maintaining FDA compliance, ISO/EC/CMDR certification, and other international standards as required.
4. Knowing and applying Exactech’s Quality System and any appropriate federal and international standards
5. Providing knowledge and support to the company’s different teams to enable operation within company and regulatory guidelines relative to PMA products, purchasing and biologics.
6. Represent the process during external audits, e.g., FDA and ISO.
7. Assist the Documentation Control Department as required to maintain compliance relative to Quality System documentation and record keeping.
8. Assisting and supporting other employees, teams, and sales personnel as necessary.
9. Practice Exactech’s Values.

Job Requirements:
Education: Bachelor’s Degree from an accredited institution required.

Experience:
• Minimum 4 years experience in FDA/ISO medical devices or equivalent quality management system regulations required
• Minimum 4 years experience in corrective and preventive action systems, including complaint handling, adverse event reporting and corrections and removals, and auditing, required
• Technical writing skills required
Functional/Technical Knowledge, Skills and Abilities Required: • Working knowledge of windows based office productivity tools including word processor and spreadsheet
• Well developed verbal and written communication skills
• Detailed oriented with strong organizational skills
• Self-directed, capable of setting own priorities and working independently to meet established deadlines

Competencies: To be completed by Human Resources.
Core:

Work Standards Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Contributing to Team Success Actively participating as a member of a team to move the team toward the completion of goals.
Building Strategic Work Relationships Developing and using collaborative relationships to facilitate the accomplishment of work goals.
Initiating Action Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
Decision Making Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
Planning and Organizing Establishing courses of action for self and others to ensure that work is completed efficiently.

Functional:
Program and Project Management Participate in program and project development, disseminate project information and are active participants in project-related work groups and committees. Actively participate in and provide recommendations to achieve goals. Facilitate meetings whenever necessary, contribute to planning and decision making, coordinate project resources and collect and disseminate project information.
Project Communication Communicates effectively in both oral and written forms, with a strong emphasis on technical writing. Deliver engaging, informative, well-organized presentations (When applicable), provide status reports and progress updates as needed and communicate difficult or sensitive information tactfully.
Negotiation Effectively exploring alternatives and positions to reach outcomes that gain the support and acceptance of all parties.

Physical Requirements:
Type ONE ‘X’ for each Activity to indicate the appropriate Physical Requirements:
ACTIVITIES ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS
Mobility X

  • Frequent sitting
  • Limited standing, walking, climbing, crouching, bending, pushing, or pulling
  • Occasional sitting
  • Occasional standing, walking, climbing, crouching, bending, pushing, or pulling
  • Limited sitting
  • Frequent standing, walking, climbing, crouching, bending, pushing, or pulling

Travel X

  • Limited travel or overnight ? Occasional travel or overnight
  • Frequent travel or overnight; including international

Visual/Hearing X

  • Normal or corrected vision and hearing ? Normal or corrected vision and hearing
  • Not colorblind
  • Normal or corrected vision and hearing
  • Not colorblind
  • Can distinguish varying or specific colors, patterns or materials
Language
  • Understand, speak, read and write basic English X
  • Understand, speak, read, and write fluent English
  • Understand, speak, read and write fluent English
  • Understand, speak, read and write fluently in a foreign language

Physical Activity X

  • Lift approximately 0-25 lbs.
  • Use of fine motor hand functions
  • Lift approximately 25-50 lbs.
  • Use of fine motor hand functions
  • Lift approximately 50+ lbs.
  • Use of fine motor hand functions

Environment X

  • Typically indoors
  • Typically in a consistent temperature
  • Occasionally outdoors
  • Occasionally exposed to varying degrees of hot and cold environments
  • Frequently outdoors
  • Frequently exposed to varying temperatures from below 32 degrees to above 80 degrees

Operating Room Entry X

  • Typically in office environment without a need to enter the OR
  • Infrequent entry to the OR. No credentialing required.
  • Frequent entry to the OR. Must be able to clear all credentialing and vaccination requirements

Valid Driver’s License X

  • Not required
  • Helpful but not required
  • Required for position

Environmental Considerations:
Type ONE ‘X’ for each Activity to indicate the appropriate Environmental Considerations:
ACTIVITIES ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS
Safety X

  • Typically not in a manufacturing environment, no special safety considerations ? Typical manufacturing environment
  • Safety glasses required
  • Typical manufacturing environment
  • Safety glasses required
  • Steel Toed shoes required

Blood borne Pathogens X

  • No risk of exposure ? Limited risk of exposure to blood borne pathogens ? Likely exposure to blood borne pathogens

Chemical X

  • No risk of exposure ? Limited risk of exposure to hazardous chemicals ? Exposure to hazardous chemicals

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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