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 Job Summary: The primary purpose of this job is coordinate and centralize technical documentation, activities, and materials to support respective areas of responsibility (Ex. R&D, Product Development, Engineering, Quality, Operations, etc.). Develops, maintains, and refines technical document control records, procedures, and processes. Contributes to achievement of team goals and objectives, as well as those of related teams. Accountabilities & Responsibilities:
- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Confers and coordinates with respective department(s) to create and edit drawings, bills of materials, routers, and other applicable technical documentation.
- Examines documentation to verify completeness and accuracy of data and resolves discrepancies with document originators.
- Initiates, monitors, and tracks change requests through electronic change control system, following documented quality and change control processes.
- Analyzes and develops solutions to improve current processes; ensures others are aware of and adhere to procedures.
- Ensures compliance with all applicable and required standards (Ex. Good Manufacturing Practice (GMP), Quality System Regulation (QSR), etc.).
- Actively participates in external and internal audits.
- Interfaces with vendors, Supply Chain, Supplier Quality, and any other respective parties to coordinate material documentation and inspections.
- Assists project managers and executes project work as assigned.
- Assists in maintaining respective project documentation and records.
- Performs other duties as required.
Education & Experience:
- Minimum Education: Associate's degree in business or related field
- Minimum Experience: 5 years' experience in business, technical, or related field OR Bachelor's degree with 2 years of experience in related field.
Knowledge & Skills:
- Special Skills:
- Ability to read and edit technical drawings, using a 2D or 3D drafting tool (Solidworks/AutoCad etc.)
- Highly organized, detail oriented, and quality minded
- Ability to work independently, prioritize and ensure tasks are completed
- Strong written and oral communication
- Experience working with cross-functional teams
- Specialized Knowledge:
- 3+ years documentation/change control experience, engineering environment preferred
- Working knowledge of Oracle, or similar ERP Platforms
- Knowledge/experience with ISO9001-2015 desirable
- Working knowledge of MS Office suite: Word, Excel. MS SharePoint and MS Project a plus
- Working knowledge conferencing software (Video, WebEx, Cisco, etc.)
- Working knowledge of material management
- Knowledge/experience with product development life cycle processes (Design Control)
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
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