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
What you’ll do in this role:
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 engineer in 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.
Specific Supplier Quality responsibilities:
- You will manage supplier non-conformances, liaising with suppliers to ensure all issues are adequately addressed
- You will manage and conduct supplier audits, tracking the closure of any audit related findings.
- You will lead the suppliers’ product and process change notification system, as applicable
- You will lead Supplier Quality Agreement management process with suppliers.
- You will work with Suppliers, Management, Supply Chain, Engineers and Manufacturing associates in the resolution of supplier quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
- You will be responsible for managing the sourced item qualification process and ensuring all appropriate documentation is completed.
- You will be responsible for managing the First Article Inspection process.
- You will monitor supplier related KPIs, 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), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
- You will be supplier quality resource for any site continuous improvement projects.
- You will support product transfers.
- You may provide supervision for up to 3 engineering direct reports. As well, you will serve as a coach and mentor for other engineers, modeling the behaviors and disciplines of an engineering or technical professional.
- 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.
Support Non-Conforming Material Process:
- You will ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures and assure adequacy of supplier corrective actions to prevent re-occurrence.
- You will lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification.
Support Site Quality Activities:
- You will support and lead internal quality audit activities, as applicable
- You will support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality.
- 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 5 Sigma.
- 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 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
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:
- At a minimum you have earned a 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.
- 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.
- 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.
- #IND1
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
