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Job Field: Office Jobs
Location: PORTLAND, WA
Salary: $-
Job Type: Full Time

JOB SUMMARY:

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               <td align="left"><font style="font-size: 100%;">REQUIREMENTS:  * Bachelor's Degree in Engineering or related field  * Minimum of 7 years leadership / management experience in regulatory and quality environment  *Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE and other international standards  * Strong record of successful US and International regulatory submissions  * Problem-solving skills and the skills to train teams to resolve various issues using available tools  * Familiarity with Lean Manufacturing concepts  * Knowledge and experience with ERP / MRP systems and their applications (SAP)  * Organizational skills with extensive knowledge of MS Excel, Word and Outlook  * Skills to work with little supervision  * Skills to motivate others to work as a team towards a common goal, and a strong balance of strategic and tactical approaches, team building, training, coaching and development  * Comprehensive understanding of ISO 9001   * Skills to execute improvement plans and activities which achieve expected results  * Skills to communicate at all levels of the organization in order to influence and get buy-in on process changes and system improvements to better meet customer requirements    PREFERRED:  * This employer prefers applicants with a National Career Readiness Certificate (NCRC)  * Master's Degree   * Experience in medical device manufacturing   * Bilingual English / Spanish and / or Portuguese   * ISO 13485 and FDA GMP title 21 Part 820 experience    JOB DUTIES:  * Maintain and enhance existing departmental functional systems in a manner that effectively supports the growth of business  * Understand business needs and implement an aligned strategic plan   * Provide leadership and direction in the implementation of Quality and Regulatory policies, procedures, and strategies, as well as prevention-based quality improvement programs that assure domestic and international regulatory compliance  * This position requires a strong emphasis on design control and regulatory compliance aspects of product development, product release, complaint handling, document control, manufacturing, supplier management and quality system compliance to ensure the development of safe and effective medical device products    HOURS:  * Full-time, permanent position    LOCATION: Portland Metro Area  Language skill requirement or preference:  Able to speak Portuguese preferred. Able to read Portuguese preferred. Able to write Portuguese preferred. Able to speak Spanish preferred. Able to read Spanish preferred. Able to write Spanish preferred.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          </font></td>
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KEY REQUIREMENTS:

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84 Months