What You'll Do in This Role
Primary purpose of this position is to perform work utilizing general engineering methods and tools; apply engineering concepts to resolve acute or chronic problems, ensuring customer expectations are met or exceeded under the guidance of senior engineers.
Responsibilities
Ensure adherence to Integer's Values and safety, environmental, security, and quality requirements, including QMS, FDA regulations, company policies, and other applicable standards.
Specific Supplier Quality responsibilities:
Manage supplier non-conformances, liaising with suppliers to address issues.
Conduct supplier audits and track closure of audit findings.
Lead supplier product and process change notifications and Supplier Quality Agreement management.
Collaborate with Suppliers, Management, Supply Chain, Engineers, and Manufacturing associates to resolve supplier quality problems.
Assist with capability studies and application of statistical quality control (Cpk, DOE, hypothesis testing).
Manage sourced-item qualification and first-article inspection processes.
Monitor supplier-related KPIs, assure compliance with DMR, provide deviation/waiver guidance, and ensure Device History Records are complete and correct.
Review adequacy and correctness of changes to BOMs, Incoming Inspection Plans, Drawings, Component Specifications, and FMEAs.
Act as supplier quality resource for continuous improvement projects.
Support product transfers.
Supervise up to three engineering direct reports; coach and mentor other engineers.
Investigate opportunities for product and process improvements following standard quality management and production system methodologies.
Support Non-Conforming Material Process: ensure disposition of supplier-caused non-conforming materials meets procedures; lead site SCAR activities, including data analysis, root-cause analysis, and effectiveness verification.
Support and lead internal quality audit activities; support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality.
Embed Quality—act as a standard bearer, ensuring adherence to QMS, supporting CAPA investigations and implementation, and contributing to quality KPI attainment and the 5Sigma journey.
Support Integer's Manufacturing Excellence and Market-Focused Innovation strategies, aligning site Hoshin and Quality plans, validating master plans, and reporting QARA metrics.
Lead sustained change initiatives, ensuring customer change notifications are completed and continuous improvement activities are executed.
Lead standardization efforts via workplace organization & visual controls (5S), manufacturing standard work, and training programs.
Promote associate engagement through standardized problem-solving methodologies, behavior-based safety programs, and suggestion systems.
Optimize systems & processes adopting built-in quality principles.
How You Will Be Measured
Safety compliance (support Environmental, Health & Safety programs).
Adherence to Integer Values (Customer, Integrity, Candor, Inclusion, Collaboration, Innovation).
Defined goals and objectives with key projects and milestones.
Quality metrics: Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time.
Innovation and ideation: generate continuous improvement suggestions and support implementation.
What Sets You Apart – Qualifications
Minimum education: Bachelor's degree in engineering or related field and 3years relevant experience; alternatively, candidates with 7+ years relevant experience may be considered without the education requirement.
Awareness of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, UL, MDD, TGA).
Good knowledge in Microsoft Office.
Ability to work independently and collaboratively with cross-functional teams.
Strong written and oral communication competencies (English for non-US applicants).
Calm demeanor under high-energy, constantly changing production environment.
Positive, can-do attitude; belief that failure is not an option.
Equal Opportunity Employer
Integer is an equal-opportunity employer.
We do not discriminate based on race, color, sex, religion, national origin, and any other protected characteristics.
Integer employs and advances people regardless of disability status, veteran status, or other protected group.
Reasonable accommodations are provided as needed.
Integer does not discriminate against veterans or individuals with disabilities and follows applicable policies.
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