Job Category: QualityJob Description:JOB SUMMARY:Supervises the activities for receiving, reviewing and processing all product inquires for complaint evaluations, as required by applicable regulations, standards and company policy. Responsible for overseeing Corrective and Preventive Action (CAPA) investigations, Midmark Investigation (IM) and Record Document Control processes. Maintains control of Quality System records per retention requirements.ESSENTIAL/PRIMARY DUTIES:
Ensure proper training of all teammates within the department.
Create and maintain department work instructions in compliance with FDA and ISO standards.
Coordinates activities to improve efficiencies within the team.
Track and post updates of improvements.
Assist and provide back-up to direct reports.
Quality System document reviews.
Document transfer reviews.
File accuracy audits.
Record control establishment and identification.
Audit support (Internal/External).
Best practice identification and implementation for compliance.
Maintains a positive and creative work environment.
SECONDARY DUTIES:
Manages department budget
Management Representative.
EDUCATION and/or EXPERIENCE:
Associate degree (A.S.) or higher; and 5 - 10 years related experience and/or training; or equivalent combination of education and experience.
COMPETENCY/SKILL REQUIREMENTS:
A high level of business acumen and comfort working in a cross functional environment
Excellent communication (written/verbal) and interpersonal skills with ability to influence.
Analytical capability with demonstrated adeptness at problem solving and ability to not only view details but also understand big picture implications.
Process oriented, proactive and customer focused.
Strong problem-solving skills.
Flexible, detail oriented, and able to quickly act under pressure and meet deadlines.
Strong project management skills with demonstrated ability to work on multiple projects.
Strict attention to details, careful risk assessment, strong customer service, effective communication and strong data analytical skills.
SUPERVISORY RESPONSIBILITIES:
Directs the daily activities of Post Market Surveillance Specialists and Document Control personnel.
Develops staff members toward superior functional performance and/or for potential promotional opportunities.
Ensure compliance with legal and Midmark policies.
Interviewing, hiring, training, planning, assigning and directing work.
Conduct performance evaluations and disciplinary actions.
Address complaints and resolve problems and conflicts.
About Us:Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.EO/AA Employer Minorities/Females/Protected Veterans/Disabled
