Summary
The primary function of this position ensures company policies and procedures are executed, relevant, and compliant with internal and external requirements such as ISO13485 and FDA’s QSR. All duties should be aligned with ARCH Medical Warsaw priorities of safety, quality, meeting commitments, and innovation.
Duties and Essential Job Functions:
- Support the development and maintenance of ARCH Medical Solutions- Warsaw’s Quality Management System (QMS), designed to meet the minimum regulatory and quality requirements to assure compliance with FDA Quality Systems Regulations (QSR) and ISO13485 requirements.
- Provide support to ensure ARCH Medical Solution is maintained in a state of compliance with current good manufacturing practices (GMP) as directed by 21 CFR 820.
- Appropriate an effective corrective and preventive (CAPA) actions and CAPA coordination throughout the company’s QMS in response to pertinent observations from the audit program, external regulatory agency inspections, complaints and other procedural/product non-conformances.
- Develop or enhance training methods and / or matrices for employees and maintain the lifecycle (create, update, terminate) of employees training. Update employee training upon supervision, assist supervisors/managers with creating gap analyses, and create periodic reports.
- Assist in supplier quality activities, including supplier evaluation, information gathering, risk assessment, etc.
- Perform and assist with internal, supplier and third-party audit preparation along with coordinating closure of findings.
- Work closely with cross-functional departments in understanding, identifying gaps and proposing changes to processes that affect quality systems compliance.
- Maintain change control and deviation processes on approved procedures, standardization and requirements associated with QMS and other GMP documents.
- Investigate deviations against the QMS and develop effective corrective action plans, ensuring tasks have been completed prior to implementation, including impact and risk assessment, testing, verification and validation.
- Initiate and maintain equipment and software validations, adhering to the validation requirements per ISO 13485 and 21 CFR 820.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Personal Effectiveness Competencies:
- Excellent organization, writing, and communication skills.
- Must be self-motivated and capable of working independently.
- Ability to handle confidential information.
- Ability to show initiative.
Required Education:
- A minimum of a High School Diploma or equivalent required, bachelor’s degree preferred.
- Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Required Experience:
- A minimum of 3 years’ experience in the medical device industry or equivalent including knowledge of FDA, ISO13485 and GMP requirements.
Workplace/Technical Competencies:
- Ability to multi-task and work under deadlines.
- Good interpersonal skills and phone etiquette.
- Demonstrates the ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Ability to write and record data and information as required by procedures.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- PC Literacy, Windows, Microsoft Office Software along with ARCH Medical Solutions- Warsaw software programs, i.e., JobBoss² and IdeaGen (Inspection Expert).
Physical Demands:
- Ability to maneuver throughout the facilities as needed.
- Comply with all safety policies and procedures including wearing proper PPE.
- Ability to function in a position which is primarily repetitive daily administrative functions.
- Visual acuity is necessary to do the job safely and effectively.
Additional NotesARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties.
All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
