Burke Porter, an Ascential Technologies Brand · 5 hours ago
Quality Engineer
Ham Lake, MN
Full-time
Onsite
Mid, Senior Level
3+ years expBurke Porter, an Ascential Technologies Brand, is seeking a Quality Engineer who will be responsible for ensuring the quality of process inputs, work outputs, and compliance of work practices in manufacturing. The role involves supporting various quality systems, troubleshooting, and implementing compliance improvements while collaborating with cross-functional teams.
Manufacturing
Responsibilities
Serve as a primary resource and technical subject matter expert in the areas of troubleshooting, problem solving, process/method improvement, and the assurance of quality and compliance of manufacturing related activities
Provides expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance
Identify trends in quality/compliance to support root cause analysis and CAPA completion
Identify and implement quality or compliance improvements with an in-depth analysis of situations and/or data
Support the implementation and enhancement of the company’s QMS
Author, participate in, and/or approve standard operating procedures, forms, test procedures, validation/qualification protocols and summary reports, internal audits, training, technical investigations, and other documents and activities requiring quality assurance/control involvement
Support cross functional teams to promote and achieve quality and regulatory objectives
Participate in other essential responsibilities as assigned
Provide direct customer communication and support to manufacturing productions
Supports audit and inspection preparation and may support responses to observations
Create a team approach to quality objectives and promote 'quality as a culture' across all company departments
Apply an advanced knowledge of commercial pharmaceutical operations quality principles and regulatory compliance requirements
Operate with minimal level of direct supervision
Perform duties following Company quality and safety standards
Participate in team building, training, and department communications
Understand and follow all attendance related policies
Maintain a high level of personal and professional integrity
Perform additional job responsibilities as assigned
Qualification
Required
Must have a BS in Scientific/Technical discipline or a minimum of 3 years of working experience in a quality engineering or related role
Must have a minimum of 2 year of experience in a medical device and/or pharmaceutical manufacturing industry
Experience in 21 CFR part 4, 210, 211, and/or 820 GMP regulations. Knowledge of standards, current industry practices, and familiarity with interpretation and application
Must have strong written and verbal communication skills in the English language
Must have strong computer skills and previous experience with MS Office products
Preferred
5 years of commercial manufacturing quality assurance experience
5 years of medical device and/or pharmaceutical manufacturing experience
Previous experience with inspections, auditing, statistical analysis, root cause analysis tools, CAPA, nonconformance and product complaint investigations, annual product review, qualifications, risk assessment models, field actions, change control, document control, validation concepts (process, equipment, computer and cleaning), product and process lifecycle development, and training
Demonstrated working knowledge of quality engineering principles
Experience working and communicating directly with customers
Company
Burke Porter, an Ascential Technologies Brand
Building on its history of leadership in the automotive industry, Burke Porter is now an Ascential Technologies company.
201-500 employees
H1B Sponsorship
Burke Porter, an Ascential Technologies Brand has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2014-10-22Acquired
Company data provided by crunchbase