Quality Engineer II

Integer Holdings Corporation•Alden, NY

5d•Onsite

About The Position

The primary purpose of this position is to perform work which involves general engineering methods and tools. You will now be utilizing more advanced quality tools and concepts while developing your role as a quality engineering the medical device industry. You apply engineering concepts to resolve acute or chronic problems. You will ensure Integer internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. 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.

Requirements

Bachelor’s degree in an engineering or related field and 3 years relevant experience.
Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.
Awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
Good knowledge in Microsoft Office
Demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
Competencies in both written and oral communications.
For outside of US countries, demonstrate competencies in both written and oral English communications.
Maintain a calm demeanor that transcends the high energy, constantly changing production environment.
Possess a positive, can-do attitude with an underlying belief that failure is not an option.

Responsibilities

Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
Participate in continuous improvement projects.
Assist with product transfers.
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.
Collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.
Lead the generation and completion of protocols and reports for test method validations.
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.
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.
Ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
Lead and manage complaint investigations.
Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
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 internal quality audit activities, as applicable.
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.
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 walk to 5 sigma.
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
May perform other duties as needed and as directed by your line of supervision.