Quality Technician

Regulatory Jobs; Florida; On-site; USD 24,000 - 35,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

STERIS is hiring a Quality Technician to support ISO 9001/13485, FDA, EU MDR compliance and to assist in calibration, environmental monitoring and product release activities. The role involves problem solving, data entry and validation of batch records in a manufacturing setting.

The position supports manufacturing operations, reviews DHRs and may participate in problem-solving investigations with the operations team.

Qualifications

• Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
• Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.
• Experience with mathematical skills including ratios, proportions and basic algebra.

Responsibilities

• Assists in production line Quality investigations and associated problem-solving activities.
• May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
• Investigates production line stoppages to identify corrective actions.
• Identifies and documents product and process non-conformances.
• Participates on a Material Review Board to review and process non conformance reports.
• Reviews DHRs and supports batch record release.
• Enters and retrieves Quality data from local and global systems.
• Performs site calibration activities and recordkeeping.
• Executes environmental monitoring processes and recordkeeping.

Skills

Quality investigations

Non-conformance handling

Data entry / QA systems

Calibration & environmental monitoring

DHR review

Education

High school diploma

Associate Degree

Job description

Position Summary

We're growing and adding to staff! Come join a strong and healthy team!!

The Quality Technician is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing. Quality Technicians assist in identifying and documenting process and product non-conformances. They work with operations team members to perform and document problem-solving investigations. In addition, Quality Technicians may review device history records, authorize release of finished product/processes and execute calibration and environmental monitoring processes.

Shift schedules: Mon-Fri 9:00am-5:30pm or 9:30am-6:00pm

What You'll Do as a Quality Technician

• Assists in production line Quality investigations and associated problem-solving activities.
• May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
• Investigates production line stoppages to identify corrective actions.
• Identifies and documents product and process non-conformances.
• Participates on a Material Review Board to review and process non conformance reports.
• Reviews DHR’s and supports batch record release.
• Enters and retrieves Quality data from local and global systems.
• Performs site calibration activities and recordkeeping.
• Executes environmental monitoring processes and recordkeeping.
• Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
• Complete other duties as assigned.

The Experience, Skills and Abilities Needed

Preferred:

Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.
Experience with mathematical skills including ratios, proportions and basic algebra.

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer:

• Market Competitive Pay
• Extensive Paid Time Off and (9) added Holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term Disability Coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued education programs
• Excellent opportunities for advancement in a stable long-term career
• Climate Controlled facilities
• Tools provided

Pay range for this opportunity is $21.50 per hour. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

STERIS is an Equal Opportunity Employer.We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.We are not only committed to this policy by our status as a federal government contractor, but and we are strongly bound by the principle of equal employment opportunity.