Job Description

job summary:
Leader in medical device manufacturing is looking for Quality Associate in Marion, NC for a contract role expected to last 6 months, possible extension, possible temp to perm. This role involves leading quality improvement projects, overseeing daily departmental activities, ensuring compliance with FDA and ISO regulations, and demonstrating expertise in quality systems, scientific principles, and leadership within a medical products industry.

location: Marion, North Carolina
job type: Contract
salary: $32.00 - 37.33 per hour
work hours: 8am to 5pm
education: Bachelors

responsibilities:

• Lead daily departmental activities, supervise assigned personnel, and assist other Quality areas when needed.

• Manage self and direct reports to achieve defined quality goals efficiently, accurately, and on time.

• Lead or contribute to process/product improvement projects (e.g., PMT, QWT, Kaizen, design of experiments).

• Lead in-plant audit readiness efforts, ensuring compliance with FDA, ISO, and company quality requirements.

• Develop customer awareness and understanding initiatives for the assigned areas.

• Provide guidance and coaching to less experienced individuals within the plant.

• Demonstrate expertise and leadership in the field, being recognized across all facility levels.

Skills:

• Understand scientific strategies and be able to invent new methods or new avenues of investigation.

• Good interpersonal/communication/influencing/negation skills.

• Good project management skills.

• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.

• Must have basic English written and oral communication skills adequate to communicate with other team members.

Education and Experience:

• Bachelor\'s degree in science or engineering.

• Advanced degree in the life sciences, physical sciences or engineering, with Ph.D. is ideal.

• Lead Auditor training, ISO Lead Assessor training, with 2-3 years experience in auditing techniques, interpreting regulations and quality systems.

• Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.

qualifications:

• Experience level: Experienced

• Education: Bachelors

skills: * Quality

• Compliance
• Manufacturing
• FDA Regulations

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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Randstad