Quality Manager

We build leaders in precision.

ARCH recognizes and rewards our employees’ contributions with a competitive total rewards package.

• 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

Join our team if you thrive in a challenging, meaningful work environment and take pride in precision, accountability, and craftsmanship!

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.

• 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.

• 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.

• 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

ARCH Global Holdings LLC is an Equal Opportunity…