Document Control Administator
Integer Holdings Corporation
Plymouth, Minnesota
Part-Time
$24
OfficeManager
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical DeviceOEMsto enhance the lives of patients worldwide and high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.
Whatyou willdo in this role:
The primary purpose of this position is to support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines. Carries out responsibilities under clearly defined procedures and / or underminimumsupervision.
Adhere to company policies and procedures and all safety and quality requirementsincluding, butnot limited to: Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required in your location.
Provide administrator support for change record implementation in line with standard operating procedures.
Control distribution and retrieval of documents including electronic files of controlled documents.
Notify applicable functions when local external documents change (as required).
Manage and control access to on-site and off-site records and documents.
Perform annual record disposition review.
Compile / complete quality records, reports and / or documentation ensuring Good Documentation Practices (GDP) are applied.
Review Device History Record (DHR) in accordance with applicable procedures and Good Documentationpractices
Assist the Quality department during audits.
Provide support / guidance and analysis to other departments.
Train personnel in proper techniques to utilizesystems,and processes.
Performs other duties as required.
Grow on the job and help others succeed.
Expands skill base through on-the-job training, cross training, and classroom instruction.
Ensure Alignmentonthe Corporate Strategic Initiatives
Continually seeks to drive improvements in process quality.
Identifies and escalates quality non-conformances to assist in achieving company quality objectives and key business metrics.
Adheres to Integer Core Beliefs, Safety and Quality requirements and applicable regulations described in the quality management system (QMS).
Embed Quality within your daily work life – “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS).
How you will be measured:
The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.
Safety is our highest priority; you are an active supporter of the Integer Environmental, Health & Safety programs.
Live the Integer Values through leading by example.
Assist the site in achieving its annual goals for safety, quality, delivery, cost, and inventory.
Achieve all Goals and Objectives assigned.
What sets you apart:
Minimum Education:Diploma/ or equivalentin administration preferred.
Minimum Experience:3-4 years of experience. Developed specialized skills in their area and other related areas. Capable of working under minimum Supervision.
Special Skills:
Leadership
Provides informal guidance and support to junior team membersand other users.
Effective communication skills (both oral and written)
Responsible for explaining technical information or data.
Strong organizational skills (including time management and ability to prioritize and meet deadlines).
General computer operation skills (e.g., Microsoft Teams, Excel, Word)
Attention to detail when reviewing and preparing documents.
Problem Solving
Capable of providing solutions to problems in situations that are infrequently occurring.
Specialized Knowledge: ProficientUnderstanding ofElectronic documentation systems, Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820), andOffice Management and Administration skills
Salary range for this position is $24.59-$36.07 per hour
#IND1
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base wages, a cash-based incentive program supporting our pay-for-performance philosophy, overtime pay, shift differentials, and call-in pay, when applicable. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.