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Director - Quality Assurance and Regulatory Affairs

Company: Mesa Laboratories
Location: Bozeman
Posted on: April 15, 2019

Job Description:

Position: DIRECTOR - QUALITY ASSURANCE AND REGULATORY AFFAIRS Posting Expiration: Posting expires 29-APR-2019. Screening of resumes will begin on 15-APR-2019; to ensure full consideration, resumes must be received by 5:00 pm MT on 29-APR-2019. Position and Version #: JOB-BPF-501 v7 Location of Position: Bozeman, Montana Reporting Relationship: This position reports to the Vice President of Operations, Sterilization and Disinfection Control. Job Classification: Salaried Supervisory Responsibilities: Supervises the positions of Quality Assurance Manager, Analyst - Quality Control, Analyst - Quality Control Lead, and Metrology (Calibration/Validation Technicians). Scope of Position: This position has oversight Quality Assurance, Quality Control, Document Control, and Regulatory Affairs for Mesa Lab locations in Bozeman, MT and M--nchen, Germany - Simicon). This position has the ultimate jurisdiction where quality related issues arise within the divisions of Assembly and Packaging and/or Laboratory Production. The Director is a member of the Bozeman Management Team (BMT). The BMT has control of the manufacturing processes and procedures and is expected to successfully execute the daily operations. This position is accountable to the members of the BMT and are expected to work together to made decisions in the best interest of the organization. Essential Duties Core duties and responsibilities include, but are not limited to, the following: -- Model personal Lean Philosophy 5S behaviors in creating a continuously improving, clean, well-organized and self-maintaining work environment. Work closely with team members and others to motivate and improve 5S knowledge and implementation. -- Follow a continuous improvement approach for team accountability for achieving high performance SQDC (Safety, Quality, Delivery, & Cost) targets through a visual work environment. -- Comply with company ethics, code of conduct, policies, and best practices, with a commitment to safety in the workplace, valuing of diversity, and promotion of a harassment-free environment. -- Responsible for oversight of the Quality System for SDC Operations as described in the Quality Manual -- Ensure compliance with federal and international regulations relating to the organization's products and quality system. -- Ensures that procedures and work instructions are followed. -- Performs quality assessment of critical suppliers -- Oversees onsite inspections and communications with regulatory bodies. -- Completes and submits 510(k) documents to the Federal Drug Administration (FDA) for clearance on relevant products. -- Maintains compliance with ISO quality systems. -- Sets goals and expectations for direct reports. Essential Duties (continued) -- Ensures all QA/QC employees have the appropriate skills, knowledge, abilities, training and tools to execute their responsibilities. -- Manages/supervise employees with regards to employee relations, training, disciplinary issues, performance management, etc. -- Responsible for achieving organization and department goals. -- Controls expenses and labor costs to conform to the manufacturing budget. -- Complies with all safety and regulatory standards. -- Perform other duties as assigned by management -- Apply the Mesa Labs Quality Policy and actively monitor quality of outcomes in the performance of all assigned tasks -- Perform other duties as assigned. Professional Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The categories 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. Education and/or Experience: -- Bachelor's Degree in scientific or relevant field -- Five years' experience in a manufacturing environment -- Ten or more years' experience in a manufacturing environment preferred -- Experience in FDA regulated industry preferred -- Experience with ISO9001, ISO13485, and ISO17025 requirements -- Three or more years' supervisory or management experience preferred -- General knowledge of global Quality standards and regulatory compliance requirements -- Any equivalent combination of education and experience Skills, Knowledge and Abilities: -- Advanced knowledge and skill with Microsoft Office programs -- Effective communication skills -- Ability to work in a team environment -- Ability to focus on continuous improvement -- Ability to take initiative and leadership on projects and tasks -- Ability to meet timelines Physical Demands: While performing the duties of this job, the employee is regularly required to stand or sit for extended periods of time. If reasonable, requests regarding ergonomic concerns will be considered. For individuals with disabilities, accommodations may be made to perform the essential functions. Occasional lifting is required. 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. This is a high volume, high energy manufacturing facility that works to meet manufacturing deadlines. An enthusiastic, positive attitude is highly encouraged and conducive to a productive successful atmosphere. Common sense judgments and problem solving is desirable. Must have the ability to handle repetitious and tedious job functions. A typical office environment and biological laboratory environment comprise the bulk of the work environment for this position. The noise level in the work environment is moderately quiet. This position requires up to 25% travel. Some of the travel is international.
Compensation: Salary, incentive bonuses, and equity will be offered commensurate with the successful candidate's experience and qualifications. Contact: Human Resources - - x10342 How to Apply: Submit current resume/CV to . Include the position title in the subject line. Posting expires 29-APR-2019. Screening of resumes will begin on 15-APR-2019; to ensure full consideration, resumes must be received by 5:00 pm MT on 29-APR-2019. Mesa Labs is an Equal Employment Opportunity Employer. Mesa Labor prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law.

Keywords: Mesa Laboratories, Bozeman , Director - Quality Assurance and Regulatory Affairs, Executive , Bozeman, Montana

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