1329 IT & Software Developer jobs in the US
Design Assurance Engineer - Quality Focused
$65,000 - 105,000
Manpower Engineering
West Manpower Place 100, Fridley
$65,000 - 105,000
Requirements
Must:
- Bachelors degree in Engineering or a related technical discipline.
- A minimum of 5 years of experience in design assurance, quality engineering, or a similar position within a regulated sector.
- Comprehensive understanding of design control mandates and risk management practices.
- Experience operating within a Quality Management System (QMS).
- Knowledge of regulatory guidelines such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971 (or equivalents in other regulated fields).
- Exceptional analytical, problem-solving, and communication abilities.
- Capability to collaborate effectively within cross-functional teams.
Responsibilities
- Lead and oversee design assurance initiatives throughout the entire product lifecycle, from conception to commercialization and post-market activities.
- Ensure adherence to relevant regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC standards as applicable).
- Engage in design control procedures, encompassing design planning, inputs and outputs, verification, validation, and design transfer.
- Facilitate and take part in risk management efforts, including hazard analysis, FMEA, and risk mitigation strategies.
- Work collaboratively across departments with R&D, Quality, Regulatory Affairs, Manufacturing, and suppliers to assure design quality and compliance.
- Review and validate design documentation to confirm completeness, precision, and regulatory conformity.
- Assist in change control processes and evaluate the impact of design modifications.
- Contribute to both internal and external audits, including regulatory reviews.
- Propel continuous improvement efforts targeting product quality and development processes.
Description
We are an innovative company located in Fridley or White Bear Lake, MN, seeking a skilled Design Assurance Engineer to join our dynamic team. We value the expertise our employees bring and offer a competitive salary ranging from $100,000 to $130,000, based on experience, alongside a comprehensive benefits package that includes a 10% bonus structure, medical, dental, and vision insurance with HSA and FSA options, a robust PTO plan, 401K matching, and supplemental life and disability insurance. We focus on fostering a collaborative work environment that drives excellence in product development and compliance.
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How many Business Specialist jobs are in the United States?
Currently, there are 1329 Business openings. Check also: Project-Manager jobs, Product-Manager jobs, CRM jobs - all with salary brackets.
Is the US a good place for Business Specialists?
The US is one of the best countries to work as a Business Specialist. It has a vibrant startup community, growing tech hubs and, most important: lots of interesting jobs for people who work in tech.
Which companies are hiring for Business Specialist jobs in the United States?
micro1, INNOVA Medical Ophthalmics Inc, Varis Mine Technology Ltd, Infovirtuel, Consultation Devpresso Inc, Cluster Systems, Vortex Solution among others, are currently hiring for Business roles in the United States.
The company with most openings is Jobot as they are hiring for 139 different Business Specialist jobs in the United States. They are probably quite committed to find good Business Specialists.
The company with most openings is Jobot as they are hiring for 139 different Business Specialist jobs in the United States. They are probably quite committed to find good Business Specialists.