You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Manufacturing Support
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
You will monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
You will review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
You will participate in continuous improvement projects.
You will assist with product transfers.
You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements.
You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.
Create Test Methods
You will support generation and completion of protocols and reports for test method validations.
You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
Support Non-Conforming Material Process
You will ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
You will lead and manage complaint investigations.
You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes.
Support Site Quality Activities
You will support internal quality audit activities, as applicable
You embed Quality– “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), supporting to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality.
You may perform other duties as needed and as directed by your line of supervision.
Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies
Strategy Alignment through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives, and regular updates to QA/RA weekly and monthly metrics, supporting the journey to differentiated quality.
Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
Systems & Process Optimization through adoption of principles of built-in-quality.
How you will be measured
The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation
You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time
Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them.
What sets you apart
Minimum Education
You have earned, as a bachelor’s degree, minimum, 3-year degree in an engineering or related technical/ Science field. Candidates who do not meet the education requirement may be considered with 5+ years of relevant experience. Combination of relevant experience and technical degree could be allowed.
Minimum Experience
0-3 years of experience.
Specialized Knowledge
You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
You will have good knowledge in Microsoft Office
While you will have regular support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
Knowledge of Good documentation practices development and review of quality documentation including procedures, work instructions, validation protocols, reports, and forms.
Equipment, process, utility, and computer system validation, including protocol development, execution, and report generation (IQ/OQ/PQ, Process Characterization, Process Validation, CSV, etc.). - (nice to have)
Specialized Skills
You will demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
You will demonstrate competencies in both written and oral communications.
For outside of US countries, you will demonstrate competencies in both written and oral English communications
You will maintain a calm demeanor that transcends the high energy, constantly changing production environment.
You will possess a positive, can-do attitude with an underlying belief that failure is not an option.
Desriable Skills
FDA 21 CFR Part 820 and Part 11
ISO 13485 and ISO 14971
Validation lifecycle methodology
Areas and equipment qualification
Statistical analysis and problem-solving tools
Microsoft Office Suite and data analysis tools
Deep understanding of GMP and quality system requirements
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- U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
