Quality Systems Specialist

Zeus Company

Arden Hills, Northern (MN, KY)

On-site

USD 53,000 - 68,000

Full time

14 days+

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Benefits offered by this job

Competitive pay

Great benefits package

Opportunity to join a family-oriented,

Job summary

Zeus Industrial Products in the US seeks a Quality Assurance Specialist to review deviations, ensure proper dispositioning, and maintain lot history and traceability in the eQMS. You will create parts, link records, and perform audits under Quality management direction.

Ideal candidates have a high school diploma or technical degree with 5+ years in medical device QA, plus strong data handling using Word/Excel and attention to detail for compliance and continuous improvement.

Qualifications

High School Diploma or two year technical degree, or 5+ years in medical device QA.
Ability to read and interpret documents and use Word/Excel.
Excellent attention to detail and organizational skills.
Strong problem-solving and ability to apply instructions.

Responsibilities

Review and monitor deviations and nonconforming material reports in eQMS.
Ensure disposition activities and training are completed timely.
Create parts in the eQMS and link to Suppliers/Customers where applicable.
Maintain traceability records and SOP-compliant documentation.
Perform audits and Gemba walks per Quality management direction.
Assist in equipment validation activities including verification testing.
Train and mentor Quality Inspectors and Technicians.
Ensure compliance with SOPs and CER gowning/ hygiene requirements.
Assist MRB for nonconforming materials and manage deviations.
Oversee deviations for expiration and update lot history records.
Maintain accurate equipment calibration and preventive maintenance program.

Skills

Interpersonal Skills

Oral and Written Communication

Teamwork

Motivation and Planning/Organizing

Professionalism

Quality

Safety and Security

Adaptability

Attendance/Punctuality

Dependability

Initiative

Innovation

Education

High School Diploma or two year technical degree

Tools

Microsoft Word

Microsoft Excel

Job description

Review and monitor deviations and nonconforming material reports using the eQMS and ensure all disposition activities and training are completed in a timely fashion.
Ensure items and materials listed on lot history records are provided by approved vendors using accepted material. Including raw material certificates within shipping documents as required per MPI and SOP.
Create parts within the eQMS and ensure that they are correctly linked to Suppliers, Customers, and related modules when this functionality is available.
Assure that all quality system records including traceability records are scanned, stored, and retained as defined in SOPs Standard Operating Procedures (SOPs).
Perform layered process and product audits and/ or Gemba walks at the direction of Quality management.
Perform inspection, measuring, testing and data collection for critical milestone tasks. Assist Engineering, Manufacturing and Quality in support of equipment validation activities, including verification inspection/testing activities.
Train and mentor Quality Inspectors and Technicians.
Works semi-independently to perform operations under minimal supervision.
Compliance to all applicable Standard Operating Procedures (SOPs) and adherence to CER gowning and personnel hygiene requirements. Ensure others in controlled environments always follow these requirements.
Assist with Material Review Board (MRB) for nonconforming and suspect materials.
Oversee Deviations for expiration and ensure relevant deviations are included with lot history records.
Assist in maintaining an accurate equipment calibration and preventive maintenance program.

COMPETENCIES:

To perform this job successfully, and individual should demonstrate the following competencies:

Interpersonal Skills – Provide clear input to engineering and operations staff on required actions.
Oral and Written Communication – Listens and gets clarification. Writes clearly and informatively; Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Contributes to building a positive team spirit.
Motivation and Planning/Organizing - Measures self against standard of excellence. Uses time efficiently.
Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to ensure a culture of compliance; Applies feedback to improve performance; Monitors own work to ensure quality.
Safety and Security – Observes all safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes, delays, or unexpected events.
Attendance/Punctuality – Is consistently at work on time; Arrives at meetings and appointments on time.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative – Asks for and offers help when needed.
Innovation – Generates suggestions for improving work.

Qualifications

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

EDUCATION and/or EXPERIENCE: High School Diploma or two year technical degree or minimum of 5+ years’ experience in medical device industry performing quality assurance activities. Basic drawing and specification understanding.

LANGUAGE SKILLS: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals and use Microsoft Word.

MATHEMATICAL SKILLS: Must have the ability to calculate figures and amounts using basic math (i.e. decimals, addition, subtraction, multiplication and division) and use Microsoft Excel.

REASONING ABILITY: Have the ability to apply common sense; Understanding to carry out detailed but uninvolved written or oral instructions; Must have exceptional attention to detail and organizational skills.

OTHER SKILLS and ABILITIES: Ability to use industry standard measurement, inspection and test equipment and to compare measurements to documented standards.

PHYSICAL DEMANDS: 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit or stand and work at a computer. The employee may lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

This job has no supervisory responsibilities.

Compensation: The pay range for this position is $38.49–$49.00 per hour. The actual starting rate will be determined based on factors including, but not limited to, the candidate's relevant experience, qualifications, skills, education, certifications and business needs

About Us

Zeus Industrial Products, headquartered in Orangeburg, South Carolina, is the world’s leading polymer extrusion manufacturer and material science innovator. More than 50 years of experience in medical, aerospace, energy, automotive, fiber optics, and more allows us to set the bar high.

Zeus is a great place to work. Expectations are high; our work is meticulous and very precise. Zeus offers an opportunity to join a very successful, family-oriented team. Our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none. We are a leader in our field and have great relationships with our customers and team members. Many of our team members are the best at what they do in the world. Our customers are leaders in their fields. Our products help save lives.

Continuous Improvement is a way of life at Zeus. Successful candidates will have a desire and ability to take our manufacturing process to the next level. Expectations are high; our work is meticulous and very precise. You must possess the ability to work independently; and the desire to learn a variety of skills. The ability to communicate clearly is imperative, as is the ability to manipulate data using various software packages.

At Zeus, what we do matters, and we pride ourselves in “Turning polymers into possibilities.” Expectations are high; our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none.

Our employees and our customers are at the center of everything we do. Those relationships have been built on a foundation that is supported by our Mission and Vision:

Our Mission: Provide Solutions – Enable Innovation – Enhance Lives

Our Vision: Working Together – Doing It Better

Zeus is an exciting, innovative company that offers competitive pay and a great benefits package. As we continue to push the boundaries of polymer science, we’re constantly in need of new ideas, new expertise, and new team members. Are you ready to join us?

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