The posting
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 What you will do 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 under minimum supervision. Adhere to company policies and procedures and all safety and quality requirements including, but not 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 Documentation Assist the Quality department during audits. Provide support / guidance and analysis to other departments. Train personnel in proper techniques to utilize systems, 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 Alignment on the 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). You 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), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma. 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 equivalent in administration preferred. Minimum Experience: 4+ years of experience. Expertise developed through on the job training and job experience. Special Skills: Leadership Provides subject matter guidance for junior team members and other users. Effective communication skills (both oral and written) Advance communication skills to communicate complex detailed information. 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 identifying creative solutions for atypical problems. Specialized Knowledge: Proficient Understanding of Electronic documentation systems Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820) Office Management and Administration skills Salary range for this position is $24.59 - $36.07 per hour 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. Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®. Additional information is available at www.integer.net. Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination. Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via [email protected] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington. To review the Integer Applicant Global Privacy Statement, please click link below for your preferred language: English| Spanish| Malay| Chinese Thanks for your interest in working on our team!!
