ABOUT US

The Arab, AL site was established in 2007 and joined the Orchid team in 2012. Our 70,000 square foot facility employees approximately 200 team members. We focus primarily on advanced machining of complex instruments for the large joint, spine and trauma markets. Our key products are instruments, implants, and trials. A career at Orchid provides competitive benefits, the ability to take on new responsibilities, and learn and grow in your career.

SHIFT

RELOCATION ASSISTANCE AVAILABLE!

The Quality Manager assures compliance and progress towards the established goals of the organization as the quality department head and acts as the designated management representative by developing and enforcing quality standards and good business practices. They communicate and ensure customer expectations and regulation requirements are met.
WHAT YOU WILL DO

• Achieve business assurance objectives and effective operation of the compliance organization by understanding, communicating, training and enforcing compliance standards, policies and procedures throughout the business.
• Add customer value through developing procedures and providing leadership to cross functional teams, formal problem solving (including true root cause analysis), PDCA, statistical analysis to reduce variation, built in quality, etc.
• Play a key role in driving improved integration of the production and quality functions.
• Contribute information and analysis to strategic plans and reviews; preparing and completing action plans; implementing appropriate countermeasures for KPI's, identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Recommend new work methods, layouts, processes and equipment to improve performance.
• Achieve quality assurance operational objectives by serving as the appointed Management Representative per 21 CFR SS820.20(b)(3) and ISO 13485:2016 and developing and monitoring appropriate site-specific quality metrics to meet company objectives.
• Collaborate with the New Product Introduction team to support engineers focused on analyzing, developing, and implementing quality standards and processes for new product launches at the site, including customer collaboration in the development of APQPs.
• Ensures timely reporting and analysis of all customer and internal complaints.
• Manage the Corrective and Preventive Action (CAPA) system and ensures timely and effective action is taken and documented.
• Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence, determining operational and performance qualification; writing and updating quality assurance procedures. Facilitate MRB review and disposition of non-conforming product.
• Support internal and external audits of the quality systems.
• Oversee Quality Control at the site including, in process inspection and measurement, final inspection and measurement, and quality record review
• Assists the development of essential QMS deliverables including, but not limited to: complaint analysis, risk management, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation
• Engender a quality culture throughout the business, holding regular briefings with employees to continually champion the Quality cause.
• Lead and develop direct reports.
• Ensure the company's quality policy is understood and implemented.
• Ensure all Health & Safety rules are adhered to and maintain a safe environment.
• Identify areas for cost reduction and productivity improvements.
• Recommend new work methods, layouts, processes and equipment to improve performance.

EDUCATION QUALIFICATIONS

• Bachelor (Required)
• Master (Preferred)

EXPERIENCE QUALIFICATIONS

• 5+ Years of Experience in Quality (Required)
• 2+ Years of Experience in Leadership (Required)
• 2+ Years of Experience in a Leadership Position in a Manufacturing Environment (Preferred)
• 8+ Years of experience in Quality (Preferred)

LICENSES AND CERTIFICATIONS

• Certified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ) (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Accuracy and Attention to Detail - Extensive Experience
• Change Leadership - Extensive Experience
• Communication - Working Experience
• Customer Communication - Working Experience
• Computer Knowledge - Working Experience
• Data Analysis Tools - Extensive Experience
• Decision Making and Critical Thinking - Working Experience
• Inspection Knowledge - Extensive Experience
• Manufacturing Industry - Working Experience
• Organization - Working Experience
• Power BI - Basic Knowledge
• Standard Operating Procedures - Extensive Experience
• Leadership - Working Experience
• Problem Solving - Working Experience

PHYSICAL DEMANDS

• Must be able to remain in a stationary position - Frequently
• Must be able to move about the inside of the building - Occasionally
• Must be able to communicate and exchange information with others - Constantly
• Must be able to distinguish and detect information such as writing and defects - Constantly

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

WHAT WE OFFER

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values:
  • Integrity First: We do the right thing
  • Teamwork: We are one Orchid
  • Results: Our results matter

ADDITIONAL REQUIREMENTS

• Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
• Candidates must be able to provide proof of eligibility to work in the United States through eVerify

EOE, including disability/vets

Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.