- Manage regulatory and quality related projects
- Participate in internal and external audits, as required
- Coordinate and liaise with internal teams to provide guidance on regulatory and quality systems compliance
- Participate in projects to maintain and improve the Quality System in accordance with national and international standards and regulations
- Provide guidance in quality data trending and analysis; evaluate and present report of analysis
- Support both administrative and technical aspects of the Learning Management System
- Learn about Applied Medicals mission and vision and take part in a variety of Applied Learning foundational courses
- Discuss your goals and expectations with your team leaders and read and review all relevant team resources and materials
- Immerse yourself in team meetings and discussions
- Exhibit a strong technical understanding of the product lines and projects?
- Support team meetings and agendas
- Take on one or more projects that require low to moderate guidance
- Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables
- Lead moderate to complex projects with minimal guidance or direction
- Demonstrate a strong understanding of Applied Medicals Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelines
- Handle a variety of projects on your own
- Experience with Microsoft Office 365 and SAP
- Ability to work effectively within a team environment, with a commitment to meeting or exceeding customer expectations, and a dedication to continuous quality improvement
- Strong oral and written communication and presentation skills
- Proactive approach with the ability to analyze data, multitask, and prioritize daily workload
- Exceptional attention to detail and strong follow-up skills
- Bachelors degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent
- Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices and International Organization for Standardization (ISO)
- Training and mentorship with ongoing learning and development courses
- On-campus wellness activities
- Comprehensive medical and dental and vision coverage
- Education reimbursement program
- 401(k) program with discretionary employer match
- Generous vacation accrual and paid holiday schedule
- Equal Opportunity Employer
Quality Systems Specialist - Rancho Santa Margarita, United States - Applied Medical
Description
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Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.??
Position Description:Areas of Responsibility?
As a Quality Systems Specialist, you will be responsible for working within the framework of a team and performing the following activities:
Clinical Writing
This role will ensure the accuracy, clarity, and compliance of our documentation, reports, and technical materials related to our products and processes through technical writing and documentation.
Comprehensive Knowledge
The job necessitates understanding of Standard Operation Procedures (SOPs) and Learning Management Systems (LMS) processes to ensure compliance with regulatory standards, validate the proper installation, performance, and operation of equipment and systems.?
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Performance Objectives
Within your first 6 months, you will be responsible for learning about our company, contributing to various projects, and leading project management initiatives.??
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During your first 30 days, you will:??
Within 60 days, you will:??
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Within 90 days to 1 year, you will:??
This position requires the following skills and attributes:
The following skills and attributes are preferred:
The base compensation range for this role is $ $78000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process.?
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Please understand that the compensation range may be modified in the future. Each amount of pay is wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit, or any other form of compensation may be modified at the Companys sole discretion, consistent with the law.
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Our total reward package also includes the following:
All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.