Principal Supplier Quality Engineer

About the role

The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals. You will be applying intensive and diversified quality knowledge and principles in extensive assignments and project leadership. As the authority in your field, you will provide guidance and quality leadership to others across Integer.

Responsibilities

• Apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.
• Ensure Integer internal and external customer expectations are met or exceeded.
• Identify and evaluate procedures to ensure the production of quality product.
• Develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
• Apply engineering concepts to resolve acute or chronic problems.
• Conduct studies to understand capability for process and/or measurement systems.
• Provide management with technical guidance as required.
• Identify and develop appropriate documentation for process improvement and project implementation.
• Maintain liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their field.
• 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.

Supplier quality responsibilities

• Manage supplier non-conformances, liaising with suppliers to ensure all issues are adequately addressed.
• Manage and conduct supplier audits, tracking the closure of any audit related findings.
• Lead the suppliers' product and process change notification system, as applicable.
• Lead Supplier Quality Agreement management process with suppliers.
• 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.
• Manage the sourced item qualification process and ensuring all appropriate documentation is completed.
• Manage the First Article Inspection process.
• Monitor supplier related KPIs, 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), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
• Serve as supplier quality resource for any site continuous improvement projects.
• Support product transfers.
• May provide supervision for up to 3 engineering direct reports. Serve as a coach and mentor for other engineers, modeling the behaviors and disciplines of an engineering or technical professional.
• 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.

Support non-conforming material process

• 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.
• 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

• Support and lead internal quality audit activities, as applicable.
• Support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality.
• Embed Quality – "I own Quality." Assure adherence to our Quality Management System (QMS), support corrective and preventive actions investigation and implementation, and contribute to the successful attainment of our quality KPI's and journey to 5 Sigma.
• 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

• 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.
• 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.

Qualifications

You are technically renowned as a subject matter expert, a recognition you have earned through 10+ years of progressive engineering and/or technically focused roles and experiences.

You earned, as a minimum, a bachelor's degree in an engineering or related technical field. Preferably, you also have a master's degree or a Doctorate.

Skills

• Awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
• Good knowledge in Microsoft Office.
• 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, competencies in both written and oral English communications.
• Maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• Positive, can-do attitude with an underlying belief that failure is not an option.

Pay

Salary Range: $143,500 - $210,540

Benefits

• Cash-based incentive program supporting our pay-for-performance philosophy.
• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
• Immediate eligibility to participate in the 401(k) plan with company matching contributions.
• 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.