Description
Job Summary:
Responsible for supporting Project Teams and Operations with Quality Engineering support for the development, implementation, and continuous improvement support activities for R&D projects, Product Transfers, and sustaining Operations Quality.
Essential Functions:
- Adheres to Resolution Medical’s safety and quality requirements.
- Foster/sustain "Voice of Quality" and "Quality First” culture.
- Improve the quality planning system to continuously meet customer requirements through conformance to specifications at each stage of the design, manufacturing, and shipping processes.
- Develop requirements for specifying critical product requirements after collaboration with design engineering, manufacturing engineering, Customers and Suppliers, as required.
- Promote quality through process discipline and first-time conformance throughout the product development and manufacturing processes.
- Work directly with project teams, customer teams, design engineering, manufacturing engineering, and suppliers to continuously improve the quality, efficiency and effectiveness of processes and product to meet or exceed project objectives.
- Responsible for Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
- Responsible for Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
- Responsible for Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
- Understanding regulatory requirements, including process and product change impact or reporting.
- Responsible for Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.
- Responsible for Change Control - lead documentation change orders per quality system requirements.
- Responsible for Validation/Qualification - Lead/review Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), Master Validation Plan/Report, and Test/Inspection Method Validation.
- Responsible for Risk Management - use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis.
- Support backroom during audits.
- Recommend and make changes to QMS procedures, SOPs, Work Instructions, and other related documents, as necessary.
- Performs other functions as required.
Requirements
Education, Experience, and Required Skills:
- Bachelor’s degree in engineering.
- 0-3+ years’ experience in medical device manufacturing or related industry
- Excellent Internal & External Customer Service Skills
- Strong Understanding of Manufacturing Processes
- Proficient in Microsoft Office
- FDA regulations, ISO 13485, ISO 14971, CAPA, Complaint/MDR
Preferred Skills:
- Statistical and data analysis
- Leadership experience
Physical Requirements:
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift 25 pounds at times.
- Ability to sit, stand, lift, bend and stoop numerous times throughout the day
- Must have manual dexterity.
- Must have excellent hand-eye coordination.
- Must wear gown, gloves, and ear protection if applicable
Summary of Benefits
- Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
- Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
- Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
- Flexible Time Off Program
- Paid Parental Leave
- Paid Holidays
- Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.
Compensation
- The typical base pay range for this role is between $70,000-85,000/year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
- 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
