Quality Assurance Manager

Description

About Block Imaging:

If you're looking for a company that values honor, integrity, growth, and together, Block Imaging may be the organization for you. We're a fast-paced organization accepting applications for the full-time role of Quality Manager, in our Holt, MI headquarters.

Why Block Imaging?

Be part of a positive work community where team member's ideas and contributions are valued.

· Offering a healthy work life balance.

· Our culture encourages professional development and seeking out opportunities for growth.

· The medical imaging industry is a stable and growing worldwide market.

Life at Block Imaging:

Don't be fooled by our casual attire. Though casual in dress, we are an innovative group focused on making great business decisions. We've built our culture on transparency, authenticity, and teamwork. We strive to work hard and play hard; and we enjoy Summer BBQs, Holiday Parties, Annual Retreats, Book Clubs, Lunch & Learns, and the occasional Ping-Pong Tournament to let off some steam.  

Job Description:

Responsible for implementing and maintaining a company-wide quality system that focuses on customer satisfaction, and medical devices compliance, addresses non-conformances, and continuous improvement. 

Requirements

Responsibilities:

• Maintain the Quality Management System and work with quality management team to maintain ISO certification and compliance with Medical devices regulations.
• Management representative for ISO processes.
• Manage suppliers’ [PB1] performance, CAPA activities, internal audits, supplier audits, and quality alerts.
• Troubleshoot process problems, define root cause, coordinate implementation of corrective actions and verify effectiveness. 
• Interface with other departments to ensure that quality system requirements are met or exceeded.
• Handle various projects and responsibilities simultaneously and successfully meet deadlines.
• Work with other groups or individuals to resolve issues. 
• Help departments develop and deliver consistent training programs.
• Work with Director of Compliance to confirm QMS meets outside requirements.
• Other duties as assigned with or without accommodation.

Role Competencies:

• Solution-oriented, flexible and able to resolve situations with confidence and mature leadership.
• Solid organization skills that include attention to detail and multitasking ability.
• Analytical skills with the ability to evaluate need, identify options.
• Capable of working within a team and focused on building positive working relationships.
• Exceptional written and verbal communication skills including telephone, writing, and listening.
• Ability to organize work, lead concurrent projects and ensure timelines are met.
• Experience in delivering and demanding a high level of customer service.
• Must be able to discuss challenges and changes with clients and vendors.
• Proficient in Excel, Word, Outlook, keyboarding, and internet research.

Qualifications:

Education: Bachelor’s Degree in Business/Management preferred; and 1-2 years related experience and/or training; or equivalent combination of education and experience.

Skill Requirements:

• Knowledge of ISO 13485:2016
• Supply Chain industry experience preferred
• Supervisory/management experience preferred 
• Good interpersonal and management skills 
• Strong oral/written communication skills 
• Strong organizational skills 
• Highly motivated and Collaborative 

Experience: Three years of experience in quality management systems in the medical devices arena.

Block Imaging is an Equal Opportunity Employer

The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.

Benefits and Perks

We live out our mission, People Matter, through the care and benefits we provide our team. 

Health, Vision, Dental & More: Competitive insurance coverage including - medical, dental, and vision coverage.