As a Quality and Compliance Analyst you will help us establish and/or maintain compliance to a range of internal and external standards, procedures, and regulations that include cybersecurity, quality management, configuration management, risk management disciplines, Controlled Goods Program management, and ITAR related implementations. What You Will Accomplish - Your Performance Objectives | In your first 30 days you will establish a “library of answers” that will speed up completing customer driven surveys and questionnaires related to our Quality Management System (QMS), Security Systems, and general business/financial information. In your first 3 months, you will assume responsibility for the document control aspects of our QMS by coordinating internal change control, adding or removing obsolete documents and records, and supporting staff from all offices with the distribution and change management elements of the QMS. In your first 6 months, following your own successful Controlled Goods Program (CGP) Clearance, you will be assigned the role of Assistant Company Security Officer and take on responsibility for the implementation of our CGP and ITAR security clearance program. This includes administering clearance applications and maintaining precise records related to employee clearances, denials, and related information. In your first 12 months you will successfully complete training as an ISO 9001:2015 and/or ISO 27001:2013 Lead Auditor. In addition to coordinating our internal audit efforts this expertise will be utilized to assist the company in its continuous improvement efforts related to both the QMS and our cybersecurity process implementations. Who We’re Looking For - The Personal Competencies That Matter | Collaborative: You have empathy for your colleagues and customers. You demonstrate and influence cross-functional collaboration within the company and seek out opportunities to build relationships with others, especially in product-related functions and can drive initiatives forward, even when difficult personalities or politics stand in the way. Gets Stuff Done / Accountable: You are comfortable rolling up your sleeves, getting deep into the numbers, tracking down the data, and delivering on a short timeline with limited resources. Intellectually curious: You have a strong level of curiosity and care about learning. You are willing to try out new techniques and continuously improve your own skillsets and understanding. Flexibility: You understand that at growth stage companies, things will evolve, and you may have to be flexible in your approach and in your expectations. You are open-minded and adapt well to changing environments as a company grows and scales. How we work – The Core Values that Define Our Culture | We are at our best when we: - are selfless team players. We work together to achieve our goals and we put the team ahead of ourselves. - are driven to succeed exceed. We take pride in our work and in exceeding expectations. - find a better way. By seeking to understand the challenge, we work to improve the process and solution. - are simplifiers (not complicators). We focus on solutions and not obstacles. We take action and ownership. We gather the right people in the room and drive to a solution. Outline of Specific Duties | The Quality and Compliance Analyst duties include but are not limited to the following: - Coordinating the organizations document change processing, tracking, review, approval, distribution, and archiving.
- Facilitating and Coordinating the implementation of Corrective and Preventive Actions (CAPA), Deviations, and Risk Management practices to assure timely resolution, implementation, and documentation
- Coordinating emergency and high priority security/compliance incident responses
- Reviewing documents being created or revised for accuracy, completeness, and compliance
- Assisting with the authoring and revision of quality system procedures, policies, and forms, identifying changes needed to existing documentation and processes to support continuous improvement.
- Serving as a change facilitator, assisting with company-wide understanding and adopting of records management practices in alignment with established policies and regulatory requirements.
- Measure and monitor quality performance in accordance with established or newly defined KPI’s and perform statistical analysis to identify trends, special or common cause events, and to focus efforts on the vital few.
- Administer and complete customer QMS and Compliance questionnaires and surveys
- Assist with the planning, implementation, and documentation of internal QMS audits
- Administer the review and retention of other miscellaneous documentation as required
- Demonstrable technical/professional writing proficiency
- Understanding of document control principles
- Understanding/Exposure to software design and development, particularly in an Agile environment
- Experience working within a Software Development Lifecycle including Requirements, Analysis, Design, Development, Testing, Deployment, and Support
- Strong communication and relationship building skills
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