Site Quality & Environmental, Health & Safety Manager
Company: Orchid Orthopedic Solutions
Location: Santa Ana
Posted on: September 18, 2024
Job Description:
ABOUT USOrchid 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). - We are
also FDA registered and ISO 13485 certified. - -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. For more information,
please visit www.orchid-ortho.com.SHIFTNo Shift ($0) (United States
of America)A BRIEF OVERVIEWThe 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.WHAT YOU WILL DO
- 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
- Lead change efforts to improve internal rework and scrap to
improve KPI Metrics
- 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. You should expect to engage the
full organization in this area of collective responsibility
- 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
- Ensure team members have the required knowledge and skills
prior to performing job duties independently, including conducting,
documenting, and evaluating training effectiveness
- Be a coach to your team, and develop the organization's
strength through empowering the team, and driving curiosity and
resilience
- 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
- Develop the organizational competence in Problem Solving
methodology and be competent in coaching Problem Solving
- Ensure the organization develops a data analysis framework and
systems which supports efficient reporting, decision making and
supports prioritizationEDUCATION QUALIFICATIONS
- Bachelor (Preferred)
- Master (Preferred)EXPERIENCE QUALIFICATIONS
- 5+ Years of Experience in Quality (Required)
- 5+ Years of Experience in a Leadership Role (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)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 - 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 ExperiencePHYSICAL 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 - ConstantlyPAY RATE---For positions located in California,
pay for this job type falls within the following range and varies
based on scope and complexity of job responsibilities.$104,900.00 -
$168,300.00Applicants 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 matterADDITIONAL 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 eVerifyAt Orchid, we fully support a
diverse and inclusive workplace and we are an equal opportunity
employer. 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.
Keywords: Orchid Orthopedic Solutions, Irvine , Site Quality & Environmental, Health & Safety Manager, Professions , Santa Ana, California
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