Document Controller Jobs

The Document Controller (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.

Duties:

• Manage site calibration activities and recordkeeping.
• Complete document control transactions.
• Coordinate internal and external audits.
• Complete other duties as assigned.
• Review DHR’s and support batch record release.
• Support targeted Lean activities.
• Track and trend site Quality data.
• Support supplier quality and Customer assessment activities.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Manage record retention practices within the site.
• Support site inspection activities and recordkeeping.
• Manage Customer complaint investigations and complete complaint documentation.

Required Experience:

• Associate's Degree in Engineering/Scientific/Technical
• Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)

Skills:

• Communication: Constructs clear written communication. Keeps manager and co-workers informed.
• Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.
• Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions.

Pay range for this opportunity is $65,000 - $80,000. This position is eligible for a 6% annual incentive bonus.

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.

Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability. Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.

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 also we are strongly bound by the principle of equal employment opportunity.