Quality Inspector II (Med Device) jobs in United States
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Aptyx · 3 weeks ago

Quality Inspector II (Med Device)

Aptyx is a company with 70 years of expertise in the life sciences and manufacturing industries, dedicated to delivering high-quality products and services. They are seeking a talented Quality Inspector II to perform component and product inspections to ensure compliance with customer specifications and support the quality department's objectives.

ManufacturingPlastics and Rubber Manufacturing

Responsibilities

Follow Aptyx Quality system, including all applicable SOP's included in the Training Matrix
Verify that incoming materials meet purchase order specifications
Prepare station for inspection, including organization and cleaning of station
Audit samples of in-process components, sub-assemblies, and final product to ensure they meet customer specifications, provide documentation support
Perform first article inspections and prepare appropriate reports
Completely and accurately fill in Lot History Records or forms in support of manufacturing, maintain documents in accordance with Quality Manual and all applicable work instructions
Inform supervisor and/or Production Line Supervisor of issues or unanticipated non-conformances
Advise supervisor in the event of needed tool or equipment repairs
Awareness of the impact of action on quality of products (defect awareness)
Identify defects and communicate defects to supervisor and/or engineer for the product through use of the reject log or direct communication
Identify defects and communicate these defects to the Production Line Supervisor, responsible engineer, and/or quality representative
Perform Lot release testing with assistance (e.g. engineer, higher-level inspector, etc.)
Support basic tasks for equipment maintenance and CER validation activities as required by management
Maintain good working relationships with peers and co-workers
Maintain identification of materials, tools, and procedures as the device is inspected
Work overtime as required
Perform line clearance audits
Performs other duties as assigned

Qualification

Inspection experienceMedical device experienceData entryMetrology measurement toolsEngineering drawings interpretationMicrosoft OfficeAdobe programsJudgmentManual dexterityCommunication skills

Required

Vocational - High School Diploma or equivalent experience
2-5 years inspection experience (medical device experience preferred)
Computer experience and proficiency required to support business system tracking and data entry
Ability to fluently read, write, verbally communicate, and follow directions in English
Ability to work an entire shift under a microscope
Ability to work an entire shift in a cleanroom environment including but not limited to: Temperatures ranging from 68°F to 80°F, Relative Humidity ranges below 35%, Wearing appropriate cleanroom gowns, head/foot/hair coverings, non-latex rubber gloves for an entire work shift
Ability to organize and coordinate work efficiently. Complete tasks and assignments as assigned by Management and Sr. peer group
Skilled in data entry
Ability to read/interpret engineering drawings
Good hand to eye coordination and manual dexterity
Able to work on a computer and familiar with Microsoft Office (Word and Excel) and Adobe programs (PDF's)
Knowledgeable on the use of Metrology measurement tools (calipers, micrometers, vision measurement systems, inspection microscopes, and similar measurement instrumentation). Able to effectively use tools and equipment as assigned
Have and demonstrate good judgment
Maintains confidential information, in accordance with Company policy
Must be able to be trained on and retain the knowledge needed to effectively perform QA tasks

Preferred

medical device experience preferred

Benefits

Competitive pay rate and performance-based bonuses
Comprehensive health, dental, and vision insurance
Retirement savings plan with company match
Paid time off and holidays
Professional development and training opportunities

Company

Aptyx

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Aptyx has developed an excellent reputation as an industry leader in plastics processing with process offerings.

Funding

Current Stage
Late Stage
Total Funding
$17.5M
Key Investors
PNC Mezzanine CapitalCVF Capital Partners
2022-08-08Acquired
2015-12-31Debt Financing· $11.5M
2012-12-12Debt Financing· $6M

Leadership Team

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Gregg Tobin
President & Chief Executive Officer
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Michelle Ferrari
Human Resource Business Partner
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Company data provided by crunchbase