Position Responsibilities and Authorities:
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Supports production needs as scheduled.
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Performs manufacturing inspection and testing of products to ensure they meet specifications
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Maintains legible and accurate records.
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Assists Manufacturing with production issues and improvements.
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Assists in investigations and testing for new or revised production procedures.
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Adheres to approved standard operating procedures and manufacturing procedures.
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Strong problem-solving skills.
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Other duties as requested.
Qualification Requirements:
Education:
High School degree
Experience & Skills:
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Minimum of 3-5 years of assembling catheter manufacturing experience required
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Excellent manual dexterity and visual acuity required
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Professional and respectful communication skills (both written and verbal) are required.
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Ability to work independently or in a team setting.
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Organized, self-motivated, displaying a proactive approach and positive demeanor.
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Demonstrates the ability to understand the catheter assembly processes fully.
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Exhibits flexibility and adaptability to changing processes business needs, or assembly flows to maintain a positive attitude.
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Experience working in a regulated industry (medical device development experience preferred along with a solid working knowledge of FDA Quality System Regulations and ISO 13485)
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Experience working in a controlled environment room (CER)
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Skilled and able to maintain focus on repetitive tasks while following precise instructions
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Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO)
Values and Diversity:
Q'apel is an equal opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs.
Our compensation ranges are calculated by role level and neurovascular experience. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your compensation. The base compensation range for this full-time position is between $29.00/hr to $30.00/hr + equity + benefits.