Job Title: Quality Engineer
Pay rate: $50 to $60 per hour
Duration: 6 months
Location: Hybrid - Minnesota City, MN

In this role, you’ll have the opportunity to:

• Evaluate mechanical product design and identify potential design quality issues and drive technical decisions.
• Lead and support DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps.
• Lead CAPA/NCR/SCAR/complaint investigations and reports
• Supports and ensures the establishment of objective and measurable product requirements.
• Support engineering print specification definitions, development, and changes
• Lead preparation and maintenance of risk management files from product conception through post market surveillance
• Develop and maintain product release testing plans, associated test methods and procedures.
• Support design test and inspection method development and validation
• Support design verification/validation and reliability study execution
• Support contract manufacturing activities including Process Development, Process Validation (IQ/OQ/PQ), and Nonconformance Resolution
• Identifies and leads continuous improvement projects and quality systems improvements.

To succeed in this role, you’ll need:

• BS degree in an engineering or physical/life science field with a minimum of 5 years relevant experience within the medical device industry or related function (a combination of education and experience may be considered).
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance.
• Good statistical data analysis skills.
• Background in manufacturing processes for drug-device combination products related to development and commercial programs.
• Excellent verbal and written communication skills.
• Ability to collaborate with internal customers, 3rd-party partners, and CMOs.

In return, we offer you:

• Hybrid work flexibility
• A collaborative, innovative team that works as one to amplify your impact on your career, the work you do and patients’ lives.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.

Job Types: Full-time, Contract

Pay: $50.00 - $60.00 per hour

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• Medical device industry: 5 years (Preferred)
• Quality Engineer: 5 years (Preferred)

Work Location: In person

Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.