Quality Inspector (Post Market)

Applied Medical; California (MO); On-site; Full time

Job summary

A leading medical device company is seeking a diligent Quality Inspector to ensure compliance with regulatory standards. The role involves inspecting, testing, and documenting manufacturing processes, contributing to product integrity and quality assurance. Join a dynamic team focused on innovation and excellence in healthcare.

Benefits

Comprehensive benefits package

Training and mentorship opportunities

Education reimbursement program

401(k) program with discretionary employer match

Generous vacation accrual and paid holiday schedule

Qualifications

• Minimum of two years of experience with quality management systems.
• Demonstrate proficiency in both independent work and collaborative teamwork.

Responsibilities

• Conduct inspections and process returned products.
• Utilize technical measuring devices to determine product conformance.
• Collaborate effectively with cross-functional teams.

Skills

Analytical Skills

Communication

Teamwork

Time Management

Education

High School Diploma

Job description

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.

Position Description

We are seeking a diligent and detail-oriented Quality Inspector to join our team at Applied Medical. As a Quality Inspector will play a crucial role in ensuring that our medical devices meet regulatory requirements and quality standards. This position involves inspecting, testing, and documenting various stages of the manufacturing process to guarantee product integrity and compliance.

Key Responsibilities:

• Inspection and Testing: Conduct inspections and process returned products and materials,ensuring proper decontamination and disinfection protocols are followed.
• Assurance: Utilize technical measuring devices to determine product conformance in accordance with specifications and product requirements
• Documentation: Use Enterprise Resource Planning (ERP) and electronic Quality Management System (eQMS) software to document and maintain accurate records of inspection results.
• Training and Compliance: Stay updated on industry standards, regulations, and best practices related to quality control and quality assurance in the medical device field.
• Team Collaboration: Collaborate effectively with cross-functional teams, including Servicing, Customer Relations, and Regulatory Affairs, to resolve quality-related issues.

Performance Objectives:

Within your first 30 days:

• Complete training on company policies, procedures, and quality control processes.
• Gain familiarity with the laboratory environment and key stakeholders.
• Perform initial inspections of medical devices under supervision.
• Begin documenting inspection results and maintaining accurate records.
• Identify any immediate areas for improvement in quality control processes and suggest solutions.

Within 60 days:

• Conduct independent inspections of medical devices with minimal supervision.
• Demonstrate proficiency in performing tests and measurements according to established protocols.
• Consistently document inspection results accurately and efficiently.
• Identify and report any recurring quality issues and collaborate with the team to implement corrective actions.

Within 90 days to 1 year:

• Serve as a resource for other team members on quality control procedures and best practices.
• Proactively identify opportunities to streamline quality control processes and improve efficiency.
• Successfully complete any additional training or certifications relevant to the role.
• Contribute to the development and implementation of new quality initiatives or process improvements.
• Maintain a high level of quality and compliance in all aspects of work, contributing to the overall success of the company.

Position Requirements

• High school diploma or equivalent
• Minimum of two years of experience with quality management systems, such as International Organization for Standardization (ISO) 9001, ISO 13485 or 21 Code of Federal Regulations (CFR) part 820
• Demonstrate proficiency in both independent work and collaborative teamwork.
• Exhibit strong analytical skills with a meticulous and detail-oriented approach.
• Possess effective oral and written communication and presentation skills, with proficiency in English.
• Showcase a friendly demeanor, positive attitude, and a customer service-oriented mindset.
• Learn how to use a variety of measuring tools and equipment.
• Excellent time management and organizational skills

Preferred

• Working knowledge of Food and Drug Administration (FDA) and ISO regulations.
• Hands-on manufacturing experience or medical device manufacturing
• Knowledgeable of inspection and decontamination and disinfection techniques and procedures in a bloodborne pathogenenvironment

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles.

Benefits

• Competitive compensation range: $18 - 23 / hour (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

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.