Summary
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.
$5,000 Sign On Bonus!
Salary Range: $100,000-$125,000, depending upon experience.Health, dental and vision benefits that start on day 1! Generous 401k match.Primary Responsibilities• Quality management representative for FDA 21 CFR 820, ISO 13485 and AS9100 certifications. Maintain records of the audit, and coordinate response/closure to findings.• Establish and promote a work environment that supports the company Quality policy, Quality objectives and Quality system. Internal expert/resource on all quality systems implemented • 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• Lead the Management Review process • Quality representative for contract review 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 requirementsAreas & Procedures Owned: • Document control • Document retention • Management Review Board (MRB) • Calibration• Quality manual, policy, and objectives • Internal/External audit • Continuous improvement • Data analysis/management• CAPA• RMA • Product identification & traceability• Non-conforming material • Supplier qualification
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.• Bachelor’s degree in quality, engineering, or a related technical field • Minimum of 10 years’ experience in a manufacturing environment, preferably in a contract manufacturing environment• A minimum of 5 years’ experience in progressive leadership and management roles in a contract manufacturing environment • Must be a U.S.
Citizen or Permanent Resident due to contractual requirements.
Preferred Qualifications
• 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 Language Skills: • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.Reasoning Ability: • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Computer Skills: • Proficient in all Microsoft Office applications (Word, Excel, Outlook)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 occasionally required to stand; walk and sit. Specific vision abilities required by this job include 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 moderate.Additional NotesARCH Global Holdings LLC is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.
A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others.
The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
