Site Quality

2 weeks ago

Santa Ana CA, United States Orchid Orthopedic Solutions Full time

ABOUT US Orchid Orthopedic Solutions is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experience in the joint reconstruction, spine, trauma, dental and sports medicine markets. Established in 2005 with a roll-up of best-in-class medical device suppliers with 120 employees. This site specializes primarily in Swiss style turning (straight flute cutting tools and bone & plate screws). A career with Orchid provides training and growth opportunities, great benefits, including quarterly bonuses, insurance, 401(k) with company match, paid time off and employee engagement events. SHIFT
No Shift ($0) (United States of America)

The Site Quality & Environmental, Health & Safety Manager assures compliance and progress towards the established goals of the organization as the quality department head by developing and enforcing quality standards and good business practices They communicate and ensure customer expectations and regulation requirements are met. The Site Quality & Environmental, Health & Safety Manager reports to the business unit Quality Director.
Provides daily quality decisions and direction on product-related issues
Interface with customers regarding quality concerns topics that include, but are not limited to metrology, inspection techniques, quality paperwork/certifications, and performance scorecards
Conceive, present, and lead continuous improvement projects related to Quality Control and Document Control
Track and trend internal and external quality metrics to proactively solve problems
Participate in internal and/or external audits to ensure compliance to procedures and regulatory requirements
Assists in the Nonconformance and Corrective and Preventive Action (CAPA) processes to ensure timely responses to quality issues
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
Participate in regular RPN reduction activities linked to the PFMEA process to proactively prevent quality or manufacturing-related problems
Work positively and enthusiastically to promote a Quality culture and engage the organization
Lead Environmental Compliance and Employee Health and Safety at the site, partnering with the Plant Manager and HR Manager in delivering excellence in this area. Lead and develop team members following Orchid’s approach to select, manage, and develop our best team. Ensure team members have the required knowledge and skills prior to performing job duties independently, including conducting, documenting, and evaluating training effectiveness
Act as a leader within the business, both in developing and delivering Quality objectives, but also acting as business partner in delivering wider business goals
Use your knowledge of regulated industry to drive a mindset of delivering compliance, whilst ensuring that this is achieved through building a depth of understanding throughout the organization, and working cross-functionally to ensure compliance is well understood and responsibilities are clear
Engender a quality culture throughout the business, holding regular briefings with employees to continually champion the Quality cause
Be an advocate of Lean Manufacturing and use this mindset to work alongside leadership to plan and develop the activities and priorities to develop a Quality System which is compliant, yet agile
Promote and coach, ‘’quality at the source’’ and understand the role of variation reduction and process capability in driving quality performance
Ensure the organization develops a data analysis framework and systems which supports efficient reporting, decision making and supports prioritization

Bachelor (Preferred)
5+ Years of Experience in Quality (Required)
~2+ Years of Experience in a Leadership Position in a Manufacturing Environment (Preferred)
~8+ Years of experience in Quality (Preferred)
~5+ Years of Experience with Quality Systems in a Highly Regulated Industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)


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


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

Must be able to move about the inside of the building - Occasionally
We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Ability to help people live a longer, more active life
All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.

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.

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