Quality Applications Spec

ECHO Consulting Group Inc; Villalba (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

ECHO Consulting Group is a leader in quality management, regulatory compliance, and CQV for the pharmaceutical and medical device industries. The role focuses on validating quality IT systems, ensuring compliance with FDA and ISO standards, and guiding cross-functional teams.

The candidate should have a Bachelor's in Engineering or Science and 10+ years in medical devices, with strong CAPA/FCA experience and excellent communication skills. 1st shift, Villalba, PR location.

Qualifications

• 10+ years of experience in the medical device industry.
• Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485.
• Proven ability in FCA and CAPA processes within regulated environments.

Responsibilities

• Conducts a compliant validation process for quality information technology systems with formal documentation under federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestically and globally.
• Identifies requirements for compliant computerized operations and documents procedures and actions.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements and audit policies.
• Performs system administration and configuration of quality information technology systems.

Skills

Autonomy

Organizational impact

Innovation

Communication

Leadership

Knowledge & experience

Education

Bachelor's degree in Engineering or Science

Tools

Microsoft Office

Quality Management Systems (QMS)

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Responsibilities

• Responsibilities may include the following and other duties may be assigned.
• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.

Shift

1st Shift

Location

Villalba, PR

Education

Bachelors degree in Engineering or Science

Preferred Qualifications

• 10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
• Strong project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
• Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability

Skills

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
• Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
• Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law. We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.