Quality Assurance Manager - Healthcare jobs in Bangor, ME

SUMMARY

This position of General Manager of Quality Assurance will be a dynamic and experienced individual. In this role, you will be responsible for leading our quality assurance efforts across multiple plants. As a key member of our team, you will be responsible for ensuring that our products meet the highest standards of quality and compliance with regulatory requirements. This position requires a minimum of 15 years of experience in the field of quality assurance, with a proven track record of success in managing quality programs in a manufacturing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

· Develop and implement comprehensive quality assurance policies and procedures across all plants to ensure compliance with AIAG and ISO industry standards and regulations.

· Provide leadership and guidance to plant quality teams, fostering a culture of continuous improvement and accountability.

· Conduct regular audits and inspections of plant operations to identify areas for improvement and ensure adherence to quality standards.

· Collaborate with cross-functional teams, including production, engineering, and supply chain, to address quality issues and drive process improvements.

· Manage the resolution of customer complaints and quality-related issues, ensuring timely and effective responses.

· Lead the development and implementation of training programs to enhance the skills and knowledge of plant personnel in quality assurance practices.

· Monitor key performance indicators (KPIs) and metrics to track quality performance across plants and drive corrective actions as needed.

· Stay abreast of industry trends, regulatory changes, and best practices in quality assurance, and proactively recommend initiatives to enhance our quality management systems.

· Support new product launches and process improvements by providing quality assurance expertise and guidance.

· Act as a liaison between corporate headquarters and plant operations, providing regular updates on quality performance and initiatives.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Flexibility and willingness to travel frequently, both domestically and internationally is a must.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Bachelor's degree in engineering, quality management, or a related field or 15 years related experience; advanced degree preferred.

· Minimum of 15 years of experience in quality assurance, with at least 5 years in a managerial or leadership role.

· Strong understanding of quality management principles, regulatory requirements, and industry standards (e.g., ISO and IATF).

· Excellent leadership and communication skills, with the ability to effectively influence and motivate teams across multiple locations.

· Proven track record of driving continuous improvement initiatives and achieving measurable results in quality performance.

· Willingness to travel extensively to support multiple plants and engage with plant personnel, customers, and suppliers.

· Strong analytical and problem-solving skills, with the ability to analyze complex data sets and drive data-driven decision-making.

· Demonstrated ability to adapt to changing priorities and thrive in a fast-paced, dynamic environment.

· Commitment to ongoing professional development and willingness to expand knowledge in the field of AIAG quality assurance.

LANGUAGE SKILLS:

Ability to read, analyze, and interpret operational financial reports, and other documents. Ability to respond to common inquiries or requests from all departments regarding operational business. Ability to deliver trainings and speeches whenever necessary. Ability to effectively present information to all departments including top management.

MATHEMATICAL SKILLS:

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY:

Ability to define problems, collect data, establish facts, and draw valid conclusions.

AUTHORITY LEVEL:

The employee has authority in the following areas: purchasing up to $5,000.00; shutdown of any equipment for safety and reliability issues.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear and to use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms and to stand, walk, and sit. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Ability to Relocate:

• Brewer, ME 04412: Relocate before starting work (Required)

Work Location: In person