Universal Balancing (now part of Burke Porter, an Ascential Technologies Company)
Quality Engineer
Universal Balancing (now part of Burke Porter, an Ascential Technologies Company), Andover, Minnesota, United States, 55304
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Quality Engineer
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Universal Balancing (now part of Burke Porter, an Ascential Technologies Company) 1 day ago Be among the first 25 applicants Join to apply for the
Quality Engineer
role at
Universal Balancing (now part of Burke Porter, an Ascential Technologies Company) Get AI-powered advice on this job and more exclusive features. SUMMARY
Job Details
Description
SUMMARY
The Quality Engineer is responsible for offering technical and quality assurance support by ensuring the quality of process inputs, work outputs, and compliance of work practices for personnel from commercial production, validation, and plant engineering. The Quality Engineer will work directly with colleagues in the planning and execution of activities while employing working knowledge of manufacturing processes, regulations, and quality management principles. The position will be responsible for various quality systems including Audit, Investigation Systems (Quality Event and CAPA), Annual Product Review, Product Complaint, Regulatory Inspections, Technical Document Review, Change Management, and/or Supplier Quality. The Quality Engineer will collect, evaluate, and interpret performance indicator data to identify sub-standard performance, compliance gaps, and/or performance improvement opportunities. The ideal candidate for this position has a strong technical background and experience in medical device or pharmaceutical product manufacturing.
ESSENTIAL 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.
ADDITIONAL RESPONSIBILITIES
Provide direct customer communication and support to manufacturing productions. Supports audit and inspection preparation and may support responses to observations.
EXPECTATIONS
The Quality Engineer is viewed as a subject matter expert on operational quality, pharmaceutical manufacturing, work process design and control, and technical problem solving. As such, a Quality Engineer is highly visible and must demonstrate strong interpersonal communication techniques, confident decision making, and a high level of personal/professional integrity.
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.
QUALIFICATIONS
Below are the guidelines for education, knowledge, skill, and/or abilities needed to perform each essential duty satisfactorily. Reasonable accommodation will be considered for individuals who are unable to meet the required qualifications.
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.
Qualifications
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Education
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Required
Bachelors or better in Engineering or related field.
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Experience
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Required
2 years:
Medical device and/or pharmaceutical manufacturing experience.
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Preferred
2 years:
Commercial manufacturing quality assurance experience.
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Licenses & Certifications
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Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Machinery Manufacturing Referrals increase your chances of interviewing at Universal Balancing (now part of Burke Porter, an Ascential Technologies Company) by 2x Sign in to set job alerts for “Quality Engineer” roles.
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Quality Engineer
role at
Universal Balancing (now part of Burke Porter, an Ascential Technologies Company) 1 day ago Be among the first 25 applicants Join to apply for the
Quality Engineer
role at
Universal Balancing (now part of Burke Porter, an Ascential Technologies Company) Get AI-powered advice on this job and more exclusive features. SUMMARY
Job Details
Description
SUMMARY
The Quality Engineer is responsible for offering technical and quality assurance support by ensuring the quality of process inputs, work outputs, and compliance of work practices for personnel from commercial production, validation, and plant engineering. The Quality Engineer will work directly with colleagues in the planning and execution of activities while employing working knowledge of manufacturing processes, regulations, and quality management principles. The position will be responsible for various quality systems including Audit, Investigation Systems (Quality Event and CAPA), Annual Product Review, Product Complaint, Regulatory Inspections, Technical Document Review, Change Management, and/or Supplier Quality. The Quality Engineer will collect, evaluate, and interpret performance indicator data to identify sub-standard performance, compliance gaps, and/or performance improvement opportunities. The ideal candidate for this position has a strong technical background and experience in medical device or pharmaceutical product manufacturing.
ESSENTIAL 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.
ADDITIONAL RESPONSIBILITIES
Provide direct customer communication and support to manufacturing productions. Supports audit and inspection preparation and may support responses to observations.
EXPECTATIONS
The Quality Engineer is viewed as a subject matter expert on operational quality, pharmaceutical manufacturing, work process design and control, and technical problem solving. As such, a Quality Engineer is highly visible and must demonstrate strong interpersonal communication techniques, confident decision making, and a high level of personal/professional integrity.
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.
QUALIFICATIONS
Below are the guidelines for education, knowledge, skill, and/or abilities needed to perform each essential duty satisfactorily. Reasonable accommodation will be considered for individuals who are unable to meet the required qualifications.
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.
Qualifications
0" style="display: none;">
Skills
0">
0">
0" style="display: none;">
Behaviors
0">
0">
:
0" style="display: none;">
Motivations
0">
0">
:
0">
Education
0">
Required
Bachelors or better in Engineering or related field.
0">
0">
Experience
0">
Required
2 years:
Medical device and/or pharmaceutical manufacturing experience.
0">
Preferred
2 years:
Commercial manufacturing quality assurance experience.
0" style="display: none;">
Licenses & Certifications
0">
0">
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Machinery Manufacturing Referrals increase your chances of interviewing at Universal Balancing (now part of Burke Porter, an Ascential Technologies Company) by 2x Sign in to set job alerts for “Quality Engineer” roles.
Ramsey, MN $77,000.00-$115,000.00 15 hours ago Coon Rapids, MN $77,000.00-$85,000.00 6 days ago St Paul, MN $79,202.00-$106,032.00 3 weeks ago Coon Rapids, MN $77,000.00-$85,000.00 6 days ago Anoka, MN $77,000.00-$110,000.00 2 weeks ago Minneapolis, MN $72,583.00-$102,402.00 4 days ago Anoka, MN $70,000.00-$94,000.00 1 month ago Fridley, MN $75,000.00-$95,000.00 1 month ago Anoka, MN $77,000.00-$110,000.00 2 weeks ago Maple Grove, MN $42.00-$43.00 17 hours ago Maple Grove, MN $69,500.00-$132,000.00 1 week ago Quality Engineer II position at Maple Grove, MN
St Paul, MN $60,000.00-$80,000.00 2 weeks ago St Paul, MN $84,651.00-$110,000.00 4 weeks ago Quality Engineer II — Medical Device (Hybrid — Maple Grove, MN) Contract
Forest Lake, MN $75,197.00-$112,795.00 16 hours ago Minneapolis, MN $85,000.00-$100,000.00 3 weeks ago Minneapolis, MN $90.00-$110,000.00 1 week ago Maple Grove, MN $44.00-$45.00 18 hours ago Maple Grove, MN $100,000.00-$120,000.00 1 week ago Minneapolis, MN $75,000.00-$85,000.00 1 week ago Minneapolis, MN $65,000.00-$75,000.00 1 week ago St Paul, MN $60,000.00-$120,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr