Top 7 Manufacturing manager Jobs in Ashland, Me

Quality Assurance/Regulatory Affairs Manager
TEMPO Employment Services —Presque Isle, ME
- $60,000 - $80,000 a year
- Full-time
- Management
- Analysis skills
- Bachelor's degree
- Profit sharing
- Disability insurance
Quick Apply
Quality Assurance/Regulatory Affairs Manager – Presque Isle, ME
Acme Monaco —Presque Isle, ME
- Full-time
- Bachelor's degree
- Doctor of Philosophy
- Senior level

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Quality Assurance/Regulatory Affairs Manager – Presque Isle, ME
Acme Monaco —Presque Isle, ME
SUMMARY OF DUTIES: To develop, implement, coordinate, and ensure the organizations compliance to the scope of the quality management system.
Quality Assurance/Regulatory Affairs Manager
TEMPO Employment Services —Presque Isle, ME
Investigate customer complaints, conduct root cause analysis, implement corrective and preventive actions, and prepare customer responses.
$60,000 - $80,000 a year
Quick Apply

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Quality Assurance/Regulatory Affairs Manager

TEMPO Employment Services -
Presque Isle, ME

Quick Apply

Job Details

Full-time
$60,000 - $80,000 a year

Benefits

Profit sharing
Disability insurance
Dental insurance
401(k)
Paid time off
Vision insurance
Life insurance

Qualifications

Customer communication
Bachelor's degree
Task prioritization

Full Job Description

Quality Assurance/Regulatory Affairs Manager

Location: Presque Isle, ME 04769

Schedule: Full-Time Day Shift

Position Type: Direct Hire

General Purpose of Job

Develop, implement, and maintain the quality management system to align with the organization’s strategic direction and ensure devices and products comply with customer, quality, regulatory, and statutory requirements.

Essential Functions

Ensure the Presque Isle facility complies with applicable quality and regulatory requirements, including ISO 9001, EN ISO 13485, EU MDD/MDR, MHLW Ordinance No. 169, and FDA/cGMP standards.
Partner with senior management to set quality policies, procedures, goals, staffing, and budget.
Lead Quality Assurance and Quality Control functions to support compliance and organizational goals.
Develop, maintain, and improve the quality management system, including documentation, processes, and work instructions.
Report quality management system performance, risks, and improvement needs to management and regulatory authorities as required.
Review technical issues, recommend process improvements, and respond to changing business and market needs.
Work across departments and with external providers to resolve complaints, nonconformances, and other quality issues.
Oversee compliance activities for new products, validations, and the control of nonconforming product.
Monitor applicable standards and regulations and promote awareness of customer and quality requirements throughout the organization.
Investigate customer complaints, conduct root cause analysis, implement corrective and preventive actions, and prepare customer responses.
Serve as the facility liaison on quality management matters and perform other duties as assigned.

Required Qualifications / Education

Bachelor’s degree from a four-year college or university.
At least 10 years of related experience or training, or an equivalent combination of education and experience.

Knowledge, Skills, and Abilities

Proven ability to manage complex quality management systems, including ISO 9001, EN ISO 13485, 21 CFR 820, MDD, MDR, MHLW, and KFDA.
Knowledge of regulatory requirements for the devices produced and markets served.
Ability to support third-party audits by customers, registrars, and regulatory bodies.
Ability to lead quality assurance and quality control functions.
Ability to multitask and prioritize to meet organizational goals.
Analytical skills, including Six Sigma, process capability, and data analysis.
Knowledge of process and product qualification and validation.
Knowledge of device and product design and development.
Strong organizational skills and attention to detail.
Extensive knowledge of engineering, manufacturing, and product realization.
Proficiency in Microsoft Office or similar software.
Strong verbal and written communication skills.
Proficiency in time management, planning, and scheduling.
Proficiency in data interpretation and statistical analysis.
Proficiency in technical and report writing.
Proficiency in root cause analysis and problem-solving.

Compensation & Benefits

Salary range of $60,000 to $80,000 per year, depending on experience
Full-time Day Shift Schedule
Direct Hire Opportunity
Vacation, Sick and PTO time
Health, Vision and Dental
Life Insurance
Short term disability
8 Holidays
401K & Profit Sharing

Quick Apply

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manufacturing manager jobs in ashland, me

Quality Assurance/Regulatory Affairs Manager

Quality Assurance/Regulatory Affairs Manager – Presque Isle, ME

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