Quality Supervisor Jobs

About Us
Join our team in Farmington Hills, MI and enable a longer, active life. This facility is climate-controlled and focuses on plasma spray coating for spine and large joint orthopedic implants. As a member of our team you can go from making ends meet to making a living - we offer a community environment, training, internal growth opportunities', tuition assistance, opportunity to earn overtime and more.
SHIFT
DET - Shift 1 ($0) (United States of America - Michigan)
a Brief Overview
The Supervisor I, Quality is responsible for the effective, efficient, and proactive operation of test lab, calibration, document control, audit compliance, and training. Responsible for ensuring activities meet customer requirements. Responsible for providing direction to the team to ensure the day-to-day operations in assigned areas meet established KPIs.
What You Will Do

• Manage department expenses, savings, and budget.
• Administer or manage employee reviews, corrective actions, goal setting, schedules, and attendance.
• Act as lead auditor. Maintain audit schedule for both internal and external audits. Participate or conduct audits to ensure compliance to procedures and regulatory requirements. Document audit reports, audit findings, and ensure timely responses are made.
• Provide insight to relevant parts regarding ISO 13458 and 21CFR820.
• Provide assistance of supplier qualifications for approval, monitoring, or discontinuation.
• Receive purchase orders in ERP system once services have been completed.
• Stay informed about regulation/guidance/standard changes. Perform impact assessments related to changes and coordinate change implementation.
• Order supplies (office, consumable, etc.) for department.
• Manage calibration activities to ensure timely completion.
• Track and trend internal and external quality metrics to proactively solve problems
• Ensure team members have the required knowledge and skills prior to performing job duties independently, including conducting, documenting, and evaluating training effectiveness.
• Lead and develop team members following Orchid’s approach to select, manage, and develop our best team. Ensure the growth of our positive business culture through behaviors that align with our core values and leadership competencies.
• Assists in the Nonconformance and Corrective and Preventive Action (CAPA) processes to ensure timely responses to quality issues
• Assist human resources in presenting information during new hire orientation.
• Provides daily quality decisions and direction on product-related issues
• Coordinate Quality Data Reviews and Management Reviews.
• Participate in risk assessments for site processes.
• Coordinate with customer(s) or vendor(s) to respond to requests or to schedule services.
• Participate in internal and/or external audits to ensure compliance to procedures and regulatory requirements
• Track and trend KPIs such but not limited to, Audit Findings and Overdue Audit Findings.
• Escalate quality concerns to management team related but not limited to product acceptance criteria.
• Utilize One Orchid global processes to meet Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and facility financial objectives
• Oversee testing activities related to process monitoring (examples are but not limited to tensile, abrasion, packaging seal strength, product cleanliness, compressed air, and environment of cleanroom).
• Interface with customers regarding quality concerns topics that include, but are not limited to metrology, inspection techniques, quality paperwork/certifications, and performance scorecards
• Assist or enact Engineering Change Orders for improvement of processes.
• Conceive, present, and lead continuous improvement projects related to Quality Control and Document Control

Education Qualifications

• Bachelor (Preferred)
• High School Or Equivalent (Required)

Experience Qualifications

• Experience Leading Internal Quality Audits (Preferred)
• 3+ Years of Experience in a Quality Role in a Manufacturing Environment (Required)
• 1+ Years of Experience Leading a Team (Required)
• Experience in Medical Device Manufacturing (Preferred)
• Experience in a FDA Regulated Environment (Required)

Knowledge & Skills That Enable Success

• Decision Making and Critical Thinking - Working Experience
• Data Analysis Tools - Working Experience
• Computer Knowledge - Basic Knowledge
• Problem Solving - Working Experience
• Communication - Working Experience
• Leadership - Working Experience
• Quality Management - Extensive Experience
• Interpersonal Communication - Basic Knowledge
• Manufacturing Regulatory Environment - Extensive Experience

PHYSICAL DEMANDS

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

What We Offer

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