Quality Manager

ARCH•Minneapolis, MN

22h•$100,000 - $125,000

About The Position

The Quality Manager is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable. This position will develop and grow a capable team of quality assurance staff to achieve company goals and objectives.

Requirements

Bachelor’s degree in quality, engineering, or a related technical field
Minimum of 10 years’ experience in a manufacturing environment
A minimum of 5 years’ experience in progressive leadership and management roles in a contract manufacturing environment
Due to contractual requirements, this position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

Nice To Haves

Excellent communication and organizational skills
Ability to work in a fast-paced environment with multiple priorities
Demonstrated leadership behaviors including effective communication, critical thinking and decision making, change agent and a strong sense of urgency
Experience leading continuous improvement initiatives
Experience utilizing problem solving and root cause analysis methods
Green Belt or Black Belt certification
Lead Quality auditor training
Experience as a management representative with FDA 21 CFR 820, ISO 13485 and/or AS9100
High proficiency in use of computer programs including MS Office (Outlook, Excel, Word, PowerPoint) ERP systems (Epicor a plus), etc.
Experience working with QMS
Strong analytical skills and the ability to express concepts effectively, both written and verbal
Strong communication & customer-service skills
Ability to be a solid decision maker
Problem solving/analysis skills
Financial management experience
Business acumen
Change agent and ability to work with a diverse group of people

Responsibilities

Lead as the management representative for FDA 21 CFR 820, ISO 13485 and AS9100 certifications.
Establish and promote a work environment that supports the company Quality policy, Quality objectives and Quality system.
Develop and implement policies, procedures, and systems that support corporate Quality goals and objectives, and maintain regulatory compliance.
Recruit, train and manage Quality assurance personnel.
Provide direction, coaching and development of Quality personnel.
Lead MRB and CAPA process to reduce product non-conformances through training and effective corrective actions.
Investigate and manage customer complaints with internal and external customers to solve Quality issues through the CAPA process
Provide leadership on continuous improvement initiatives (lean, Six Sigma, etc.)
Monitor and report internal and external Quality metrics by collecting, analyzing, and summarizing information and trends.
Maintain validation and calibration of inspection equipment.
Organize customer Quality expectation information and contractual obligations.
Participate in creation of DMR. Specifically assure the development of part specific inspection plans to meet customer requirements and contractual obligations.
Develop robust, part specific, inspection processes that meet customer requirements.

Benefits

Competitive base salary - $100, 000 to $125,000 per year depending on experience
Medical/Prescription Drug/Dental/Vision Benefits on Day 1 of employment
401(k) Retirement Savings Plan 4.5% company match if you contribute at least 5%
Annual Bonus potential
Paid Time Off (PTO)
8 company paid holidays per year
Employer paid Life Insurance, AD & D plus optional coverage for yourself, spouse and child(ren)
Employee Assistance Program
MN Paid Leave/and/or Short-Term Disability and Long-Term Disability provided by ARCH
$5,000 Sign on Bonus