Associate Quality Systems Engineer

Job description

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 customers’ 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 Who we are: Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s to enhance the lives of patients worldwide and high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement. What you will do in this role: The primary purpose of this position is to support compliance to the Integer Quality System. As an entry level associate, you will ensure that Integer’s Quality System Requirements are met or exceeded with the direction, instruction and guidance from more experienced associates and managers in your organization. You will learn compliance to the quality system requirements to ensure the company meets internal, regulatory and customer requirements. 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. General Quality System Support and Collaboration: Under the supervision of experienced quality engineering mentors and managers, you will select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes. You will perform work on technical projects where you will follow Integer’s standard quality management methodologies to investigate opportunities for quality process improvements. You will apply standard data analysis practices and techniques to establish root cause for quality system issues. 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. Audit Support: You are responsible to Support internal and external audits. Provides support for external regulatory inspections and customer audits. Support the timely response and closure of audit observations and findings and reviews and maintains corrective actions from audit findings. Management review Support: You are responsible for assisting in preparing, coordinating, and documenting the site Quality Management Review. Issue Resolution Support: You Provide tracking and support for customer notifications. You Provide Quality Systems and Compliance consulting related to CAPA, Complaint Investigations, and other compliance topics. You Provide support for CAPA and NCR investigations as needed to insure timely and accurate processing. You complete trending and evaluation of data for quality system metrics. Additional: You embed Quality within your daily work life – “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), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality. Assists with quality assurance functions in support of needs directed by Quality Management. Performs other duties as required. Provide support of 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: 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 – Achievement of site Quality KPI’s Innovation and ideation are critical aspects of your role What sets you apart: Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field Minimum Experience: 0-3 years’ experience While you will have regular support and guidance from more experienced quality engineers and managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams. You 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 demonstrate competency in both written and oral communications. You maintain a calm demeanor that transcends the high energy, constantly changing work environment. You possess a positive, can-do attitude with an underlying belief that failure is not an option. #IND1 Salary Range $56,100 - $82,280 Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off. U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.