Quality Engineer III

Primary Purpose

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

Key Accountabilities and Responsibilities

• Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
• Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Maintains compliance with DMR while ensuring complete and correct Device History Records are maintained.
• Leads and implements various product and process improvement methodologies.
• Reviews changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Completes and maintains risk analysis.
• Develops and completes protocols and reports for test method validations.
• Reviews processes for new and existing products and coordinates process validations and capability studies.
• Recommends process monitoring devices where applicable.
• Develops various inspection techniques and procedures to ensure product integrity to design specifications.
• Writes, approves, and implements Incoming, In-Process and Final Inspection procedures.
• Ensures that the disposition of non-conforming materials meets all necessary regulatory requirements and assures adequacy of corrective actions to prevent re-occurrence.
• Communicates and interacts effectively with customers.
• Manages complaint investigations.
• Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Assists with product transfers.
• Works with suppliers, management, Engineers, and Manufacturing associates in resolving quality problems.
• Leads and manages capability studies and applies statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
• Supports other quality engineers.
• Performs other functions as required.

Minimum Education and Experience

• Minimum Education: Bachelor’s Degree in Engineering or related field required.
• Minimum Experience: 5-7 years’ experience in medical device or regulated manufacturing.

Specialized Knowledge

• Competence in the selection and use of Quality Engineering Tools and Techniques.
• Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.).
• Proficient in Microsoft Office and Minitab.

Special Skills

• Ability to work independently and in team environment.
• Ability to effectively communicate written and verbally.
• Ability to manage time effectively to ensure timely completion of tasks.
• Knowledge of SPC, FMEA, DOE, RCA, GDT.
• Sound knowledge of quality management systems.

Other

• Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.

Pay Range

$93,225 - $136,730

Total Rewards Program

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.