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Senior Engineer, Operations Quality
4 months ago
Overview
The Sr Operations Quality Assurance Engineer is responsible for compliance to procedures and regulations for Manufacturing Controls of Implant and Externals Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO13485, ISO 14971, MDSAP and MDR.
What you'll do:
Manages all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives
Partnering with Receiving inspection, Quality control and supplier quality to ensure a streamlined manufacturing process is maintained
Support 3rd party audits regarding manufacturing processes and policies
Experienced in class III sterile implantable medical devices
Provides status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and to direct management
Provides expertise to the manufacturing and design team on the implementation of international standards (ISO 14971, ISO 13485, particular standards, etc.) as they relate to manufactured product.
Identification and interpretation of recognized standards for medical manufacturing (e.g. ISO 13485, 21 CFR 820, MDSAP, EUMDR etc)
Requirements discovery as solicited from Engineering, Marketing, Clinical, and Regulatory stakeholders
Ensure product meets and exceeds product specifications, regulatory requirements, and international standards
Responsible for various testing planning, execution and reporting, including design transfer, IQ, OQ, PQ. Verification and Validation of manufacturing processes and tooling etc.
Recommends process improvements to management and executes to ensure consistent implementation of internal requirements and external regulations and standards.
Participates in the investigations and dispositions of product, non-conformances and changes, CAPA, NCMR, MRB
As needed, prepares documentation for and support regulatory submissions (USA, EU, International)
May create and/or delivery training on compliance of medical devices per international standards
May mentor, train or otherwise provide guidance to newer or less experienced team members, leveraging product skills and experience
General quality support as required and other duties as assigned.
QA representative on cross functional teams, GEMBA walks, Manufacturing Kaizen Events
Other duties as assigned.
Travelling Requirement:
10%
What you bring to the team:
Education
Bachelor's Degree (and/or # of years of equivalent work experience)
Nice to Have
Bachelor's Degree in Engineering or advanced degree
Work Experience
5 years of previous Quality Engineering in Medical Device Manufacturing
Nice to Have
5 years of previous Quality Engineering in Medical Device Manufacturing for Class III Active Implantable Devices
Personal Competencies
Must be able to work with all levels of management and ability to manage a team of engineers.
Social Competencies
Ability to work under pressure and meet project timelines across departments
Leadership Competencies
Ability to drive Continuous Improvement through collaboration and consensus building.
Professional Competencies
Must be able to work with all levels of management and peers.
Ability to maintain professionalism among peers and communicate effectively will all levels of the organization
Language(s)/ Level
English/ Proficient
Nice to Have
Spanish/ Fluent
IT Skills
Microsoft Office/Engineering Software
Nice to Have
Agile PLM; SAP
Our offer:
Exciting and challenging work environment
Comprehensive benefits package
Training and development opportunities - we believe every employee deserves a development plan. Come, learn, and grow with us
Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you
We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.
We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources.
Pay Ranges:
$91,200/yr - $136,800/yr
Health Benefits & Perks:
Medical, dental and vision coverage*
Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
TeleHealth options
401k plan with company match*
Company paid life/ad&d insurance
Additional supplemental life/ad&d coverage available
Short/Long-Term Disability coverage (STD/LTD)
STD LTD Buy-ups available
Accident/Hospital Indemnity coverage
Legal/ID Theft Assistance
PTO & paid holidays*
Employee Assistance Program
*Plan rules/offerings dependent upon group Company/location.
Sonova is an equal opportunity employer
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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