Quality Systems Specialist - 2nd shift

Quality Specialist

The Quality Specialist 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. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

This is a second shift position. Monday - Thursday 11:00am - 8:30pm; Friday 8:00am - 11:00pm OR 11:00am - 3:00pm.

What You'll Do as a Quality Systems Specialist

Complete document control transactions.

Manage Customer complaint investigations and complete complaint documentation.

Facilitate CAPA and NCR investigations and may coordinate investigation documentation.

Review DHR's and support batch record release.

Manage record retention practices within the site.

Manage site calibration activities and recordkeeping.

Support site inspection activities and recordkeeping.

Coordinate internal and external audits.

Support supplier quality and Customer assessment activities.

Track and trend site Quality data.

Support targeted Lean activities.

Complete other duties as assigned.

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

The Experience, Skills and Abilities Needed

Required:

Associate degree with minimum two (2) years of experience working in quality in a regulated industry (i.e FDA/ISO 13486). Will accept HS diploma with minimum six (6) years' experience working in a regulated industry (i.e FDA/ISO 13485) in lieu of degree.

Demonstrated "Customer first" mindset. Responds with a sense of urgency.

Collaborate with others. Works in a professional manner to support team actions.

Ability to effectively manage work tasks. Detail oriented and strives for continuous improvement.

Ability to analyze technical issues.

Ability to cope with change and shifting priorities.

Constructs clear written communication. Keeps manager and co-workers informed.

PC experience and working familiarity of common desktop applications including Excel and Word, Outlook and MS Teams.

Pay range for this opportunity is $59,075.00 - $72,975.00. 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.

Open until position is filled.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity 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.