By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customersā success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Adheres to Integer Core Value and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, company policies and operating procedures, and other regulatory requirements.
Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
Actively participate in internal audits, management review and other activities covered under
Company Quality Manual, Policies and Procedures.
Provide customer-related quality and regulatory inquiries supports.
Complies and writes training material and conducts training sessions on quality control activities.
Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost-effective manner.
Directs development and maintenance of internal/external standards relative to Design and Development.
Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation.
Lead and provide Project Management support as needed.
Develops and initiates standard methods for inspection, testing and evaluation, utilizing knowledge in related engineering fields.
Devises sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
Performs measurement system analyses to evaluate test and inspection equipment.
Leads disposition of discrepant material and devises process to assess product quality and reliability.
Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
Support supplier approval and qualification of new/revised items which includes inspection methods, supplier audits, management of suppliersā corrective and preventive actions and assist in FMEA.
Support for FDA and ISO inspections and registration.
Supports or may perform measuring, testing and tabulating.
Comply with all safety policies and safe work procedures established by the company.
Use PPE and other equipment as established in company policies and safe work procedures.
Working near cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls
Expected to attend safety training and may serve on the facility safety committee and participate in hazard analysis and resolution.
Responsible for Final Inspection and approval for releasing of goods
Initiate on and close out NCRs.
Performs other duties as required.
Education & Experience:-
Minimum Education
Bachelorās degree in engineering or equivalent
Minimum Experience
3 years working experience in manufacturing environment, preferably in medical devices with increasing responsibility.
Knowledge & Skills:
Special Skills:-
Possess excellent verbal and written communication skills which include and not limited to presentation, organizational and management skills.
Special Knowledge: -
Strong technical knowledge in required discipline.
Strong in analyzing data specifically in statistical packages and Microsoft office.
Familiar with FDA QSR and ISO 13485.
Comprehensive technical knowledge including ERP system, statistics, SPC, geometric tolerance and mechanical drawing.
Attention to details, thoroughness and dealing with complexity.
Physical Requirements: -
Physical Requirements:
N/A
Other:
N/A
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
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