QA Engineer - Manufacturing

Altor Solutions; Belcamp (MD); On-site; USD 65,000 - 95,000; Full time

Job summary

Altor Solutions in Belcamp, MD is seeking a Quality Engineer to oversee QMS documents, ensure compliance with ISO and FDA regulations, and drive quality improvements throughout development and production.

The role collaborates with engineering and product teams to prevent defects, conducts audits, maintains document lifecycle, and supports internal/external audits while promoting our quality culture.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related field or equivalent experience in Quality.
• Manufacturing industry experience preferred.
• Proficiency with Microsoft Office and QMS administration.

Responsibilities

• Organize and maintain documents related to projects, products, or operations.
• Supervise, train and mentor junior QA staff.
• Implement and enforce document control processes and standards.
• Ensure project documents are reviewed, approved and stored in a centralized system.
• Manage the document lifecycle from creation to archiving.
• Coordinate with managers, engineers and stakeholders for timely submissions.
• Conduct regular audits for accuracy and compliance.
• Support audits and inspections with relevant documentation and reports.
• Train employees in proper document management procedures.
• Maintain document control databases and systems.
• Develop and implement quality assurance policies and procedures.
• Design and maintain test plans and cases based on product requirements.
• Perform manual and automated testing of software applications.
• Identify and track software defects with the development team.
• Conduct root cause analysis and drive process improvements.
• Review product documentation for clarity and completeness.
• Collaborate with product managers and developers to ensure quality during development.
• Conduct regression testing after changes.
• Ensure compliance with ISO, FDA, or CMMI standards.

Skills

Microsoft Office Suite

QMS administration

Education

Bachelor's degree in Computer Science, Engineering, or related field

Tools

QMS software

Job description

Job Title: Quality Engineer

Job Summary

The Quality Engineer is responsible for managing the process of maintaining all documents within the Quality Management System (QMS) to ensure that documents are accurate, up-to-date, and compliant with company requirements and regulations. Additionally, this position is responsible for ensuring that products and services meet the required standards and specifications. This position will work closely with development teams to improve product quality and prevent defects with the goal of maintaining high-quality standards throughout the production process.

Essential Duties & Responsibilities

• Organize, track, and maintain all documents related to projects, products, or operations.
• Supervise, train and mentor junior QA's and staff.
• Implement and enforce document control processes, procedures, and standards.
• Ensure that all project documents are reviewed, approved, and stored in a centralized document management system.
• Manage the document's lifecycle, including creation, revision, distribution, and archiving.
• Ensure compliance with regulatory and industry standards (e.g., ISO 9001, FDA regulations).
• Coordinate with project managers, engineers, and other stakeholders to ensure timely submission of documents.
• Conduct regular audits of documents to ensure completeness, accuracy, and compliance with internal and external standards.
• Support audits and inspections by providing relevant documentation and reports.
• Train and assist employees in proper document management procedures.
• Maintain and update document control databases and systems.
• Develop and implement quality assurance strategies, policies, and procedures.
• Design, execute, and maintain test plans and cases based on product requirements.
• Perform manual and automated testing of software applications and systems.
• Identify, report, and track software defects, and work with the development team to resolve them.
• Perform root cause analysis of issues and provide feedback for process improvements.
• Review product documentation to ensure completeness, accuracy, and clarity.
• Collaborate with product managers and developers to ensure quality during the development process.
• Conduct regression testing to ensure that previously developed and tested software still works after changes.
• Ensure compliance with regulatory and industry standards (such as ISO, FDA, or CMMI).
• All other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The

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 Requirements/Work Experience

• Bachelor's degree in computer science, Engineering, or related field from an accredited college or university or equivalent experience of 2 to 4 years in the field of Quality.
• Manufacturing industry experience preferred.

Computer Skills

• To perform this job successfully, an individual should be proficient with Microsoft Office -- MS Word, Excel, PowerPoint, and experience with Quality Management System administration.

Core Values

• Accountability We take full responsibility for our actions and outcomes, ensuring transparency and trust with our stakeholders, customers, associates, and the environment. Competencies: Problem Solving, Decision Making, Planning & Organizing, Resilience, Time Management/Prioritization and Learning Agility
• Innovation We champion creativity and collaboration, continually striving to deliver groundbreaking solutions that transform our industry and exceed expectations. Competencies: Creativity & Curiosity, Continuous Improvement, Vision & Strategic Thinking, and Collaboration & Teamwork
• Integrity We uphold the highest ethical standards of honesty, transparency, and ethical behavior in every decision and action, fostering trust at all levels in our organization. Competencies: Honesty, Consistency & Dependability and Commitment to Excellence
• Adaptability We embrace change agility and resilience, staying flexible and proactive in a constantly evolving world. Competencies: Communication, Results Oriented and Flexibility
• Caring We prioritize the well-being of our people, communities, and business partners, recognizing that their success and happiness are vital to our own. Competencies: Organizational Savvy, Risk Management, Compliance, Diversity, and Empathy
• Passion We are driven by a relentless pursuit of excellence, demonstrating determination to succeed while maintaining humility and respect for others. Competencies: Commitment, Persistence & Tenacity, Humility and Respect

Physical Demands

Associate must be able to do the following:

• verbally communicate, listen to others, and take directions
• frequently sit, stand, or walk
• frequently crouch/stoop, bend or twist
• frequently reach with hands and arms (both above and below shoulder level)
• use hands, fingers, and wrists with dexterity
• must be able to work in/with/ near machinery
• must be able to work with hand tools

Max lift for one person shall be 40 lbs. (non-repetitive)

• Less than 40 lbs. require 2 person lift up to 70 lbs.
• Greater than 70 lbs. require mechanical assistance

Push/pull up to 50 lbs.

Specific vision abilities: must be able to read production tags, labels, inspect parts and identify defects if present.

Ability to wear Personal Protective Equipment (PPE) including hearing protection, safety glasses and steel/composite toe shoes, gloves, etc... Hearing protection and PPE are based on job assignment/tasks/work area.

Apply critical thinking to perform complex tasks.

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

Moderate exposure to heat, cold, and noise.

Heat/Cold exposure is subject to change depending on external weather temperatures and work location.

At times, some work areas might have wet or damp conditions.

Work in close proximity with other production associates, materials, and machinery.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by those assigned to a particular position. This document in no way states or implies that this is an exhaustive list of all responsibilities, duties, and skills required, and personnel may be required to perform duties outside their normal responsibilities from time to time, as needed. The Company reserves the right to change, modify, amend, add to or delete from, any section of this document as it deems, in its judgment, to be proper.

Requirements:

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