quality assurance senior.

Are you a dedicated Quality Assurance expert ready to ensure the highest standards of product quality and regulatory compliance? We are seeking a mid-level professional to join our team, playing a central role in maintaining the integrity of our medical devices. This position offers the opportunity to work independently on projects and collaborate with diverse teams, making a direct impact on our organization's success.   What You'll Bring:

• A Bachelor's degree in engineering or relevant ASQ certifications (CQE, CQM, CQA, CQI, and/or CQT).
• At least 5 years of experience in a similar quality assurance program or department.
• Experience with organizations certified to ISO 13485 or/and 21CFR Part 820.
• Proficiency in MS Office, including Word and Excel.
• Clear communication skills, both written and oral, across all organizational levels.
• Organizational and motivational capabilities.
• Demonstrated ability to solve practical problems and make logical decisions.
• The ability to work independently and as part of a team.
• A motivated approach, with potential to lead in a dynamic, evolving industrial environment.

Preferred Qualifications:

• 2 years of experience in a Quality Control or Quality Assurance position within a Medical Device Company.
• A Master's degree in engineering or science.
• Experience with process analysis software like Minitab or advanced Excel.
• Knowledge of medical device products and/or markets.
• Ability to travel domestically, with a valid passport or ability to obtain one for international travel.
• Experience with ethylene oxide sterilization of medical devices; Gamma sterilization experience is also a plus.

Physical and Mental Demands:

This role involves physical activity such as walking, standing, bending, squatting, reaching, and lifting up to 40 lbs. Work will primarily be in an office environment, but may also involve time on the production floor or in a warehouse, with typical office and manufacturing conditions.

If you are a driven Quality Assurance Engineer ready to contribute your expertise to a critical function, we invite you to apply!   marisela.vizcarrondodugarte@randstadusa.com

salary: $90,000 - $110,000 per year
shift: First
work hours: 8 AM - 4 PM
education: Bachelors



Responsibilities

As a key member of our quality team, you will be responsible for ensuring our medical devices meet all regulatory requirements. Your duties will include:

• Leading and managing the environmental monitoring and cleanroom certification program.
• Accurately interpreting engineering drawings.
• Applying knowledge of manufacturing protocols and continuous improvement techniques specific to the medical device field.
• Reviewing and approving protocols and risk management documents.
• Utilizing quality engineering principles, including risk management, statistical process control, and failure mode and effects analysis.
• Collaborating with cross-functional teams to design, develop, and implement quality control measures, ensuring product compliance and customer satisfaction.
• Assisting in the creation and revision of Quality Management System (QMS) documents like Standard Operating Procedures and Work Instructions.
• Managing the gauge qualification program to ensure precision and accuracy of all gauges used.

The essential functions of this role include:

• manual lifting up to 40lbs
• standing for 8 hours at one time

Skills

• Quality Assurance
• Product Inspection
• Monitoring
• Production Control
• Testing
• Quality Control
• Blueprints
• ISO 13485 (3 years of experience is required)
• QMS (8 years of experience is required)

Qualifications

• Years of experience: 8 years
• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.



Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.