Senior Quality Engineer
Senior Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job purpose
The Senior Quality Engineer is responsible for supporting the Healthcare business by developing and executing engineering and validation strategies plans and protocols to include facility equipment process and software.
Main Accountabilities and tasks
- Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity.
- Responsible to ensure device testing method development method transfers and troubleshooting and all related documentation is compliant to applicable regulations.
- Identifies and controls Manufacturing process defects (scrap nonconforming material custom complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
- Actively participates in test method development and transfer meetings to other labs representing the quality assurance function to ensure compliance with procedures.
- Support the development of Plans for development verification/validation technology transfer and risk management in line with applicable regulations for medical device products
- Provide Quality oversight for the development review and approval of key Design History File deliverables including Verification and Validation Protocols and Reports Risk Management deliverables and Transfer Plans.
- Supports root cause investigations provides compliant options for resolving lab technical and quality issues (lab investigation reports) in compliance with QMS and regulatory expectations.
- Reviews and approves complaint investigation and root cause CAPAs.
- Analyze trend and report data supporting the quality system.
- Draft reviews and approves Quality Agreements (QAG) for equipment vendor method developers and service providers.
- Other duties as assigned.
Qualifications :
Desired experience and qualifications
Work Experience: 7 years of validation experience in a regulated manufacturing environment related to quality control of medical devices per ISO 13485 and 21 CFR 820.
Education: BS degree in engineering field
Other:
- Experience with injection molding processes parameters and troubleshooting is preferred.
- Mastery of SOPs cGMPs and other compliance requirements and regulatory guidelines (FDA EU) and the know how to work and manage within a regulatory environment.
- Required experience with good documentation practices and cGMP standards.
- Thorough understanding of ISO 14971 from implementation through device lifecycle.
- Proficiency in the use of personal computers especially word processing software spreadsheets presentation and database software.
- Experience working in a clean room environment and performing process and equipment validations.
- Ability to perform work accurately and thoroughly and to work independently with minimal supervision.
- Must be organized and able to follow a systematic method of performing tasks and the ability to organize and direct a project to completion.
- Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules.
- Communication skills both oral and written as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.
- Ability to work well with subordinates peers and superiors in all departments.
Additional Information :
Benefits we offer:
- Up to three (3) weeks of paid time off beginning your first year
- Twelve (12) company paid holidays per year
- Medical dental vision Life/AD&D Short- and Long-Term Disability Identity Theft and Legal Protection plan options
- medmix Employee Savings Plan / 401k with 100% employer match up to 6% of your annual base salary
- Eligible to receive additional non-elective 401k contributions on a quarterly basis
- Health Savings Account with dollar-for-dollar matching based on coverage level
- Flexible working hours
- Employee Assistance Health and Wellness Program
- An innovative vibrant and agile culture
- Growth opportunities in a globally successful and dynamic business on a growth trajectory
- Access to a wide range of discounts on shopping entertainment and lifestyle
medmix is an equal opportunity employer committed to the strength of a diverse workforce.
93% of our employees would go above and beyond to deliver results do you have the drive to succeed Join us and boost your career starting today!
All information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
