Quality Control Inspector I
About The Position
The Quality Control Inspector I performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Requirements
- High School Diploma / GED or an equivalent combination of education and work experience
- Some - 0-2 year’s related work experience.
- Previous experience in Quality performing inspection.
- Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing.
- Training in blueprint reading and experience with inspection sampling techniques.
- Knowledge of FDA, GMP, ISO 13485.
- Good communication and computer skills, including Microsoft Word and Excel.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Must be willing to work overtime as required, including weekends
- Ability to maintain regular and predictable attendance.
Nice To Haves
- Prior medical device component inspection experience preferred.
- ASQ CMI certification preferred.
Responsibilities
- Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
- Records inspection and test data as prescribed by written instructions and procedures.
- Recommends changes to policies and procedures.
- Documents non-conformances in Non-Conforming Material Review system.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Benefits
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
