Site Quality Manager

3 days ago

Garden Grove, California, United States Orchid Orthopedics Full time
About Us

Orchid Orthopedic Solutions is a 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, our company has grown to 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

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.

Job Summary

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.

Key Responsibilities
  1. Provides daily quality decisions and direction on product-related issues
  2. Interface with customers regarding quality concerns topics that include, but are not limited to metrology, inspection techniques, quality paperwork/certifications, and performance scorecards
  3. Conceive, present, and lead continuous improvement projects related to Quality Control and Document Control
  4. Track and trend internal and external quality metrics to proactively solve problems
  5. Participate in internal and/or external audits to ensure compliance to procedures and regulatory requirements
  6. Assists in the Nonconformance and Corrective and Preventive Action (CAPA) processes to ensure timely responses to quality issues
  7. 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
  8. Participate in regular RPN reduction activities linked to the PFMEA process to proactively prevent quality or manufacturing-related problems
  9. Lead change efforts to improve internal rework and scrap to improve KPI Metrics
  10. Work positively and enthusiastically to promote a Quality culture and engage the organization
Leadership Responsibilities

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 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 prioritization.

Requirements

Bachelor (Preferred)

Master (Preferred)

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 and Skills

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

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

Pay 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, $168,300.00

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

At 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.

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