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Hours Full-time
Location Happy Valley, Oregon

About this job

ABOUT US

The Oregon City, OR site was established in 1973 and joined the Orchid team in 2012. Our 80,000 square foot facility employs approximately 300 team members. We specialize in hip and knee joint implants that enable our customers to live a longer active life. We are a full-service plant, meaning our team can manufacture medical implants from start to finish in-house. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match, and paid time off. For more information, please visit.

SHIFT

No Shift ($0) (United States of America)

A BRIEF OVERVIEW
The Supervisor, Quality is responsible for the effective, efficient, and proactive operation of quality team members and equipment in a large and/or complex area. They assume ultimate responsibility for ensuring parts shipped meet customer requirements. They are responsible for providing direction to the team to ensure the day-to-day operations in the assigned areas meet established KPIs.
WHAT YOU WILL DO

  • 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.

  • Assists in the Nonconformance and Corrective and Preventive Action (CAPA) processes to ensure timely responses to quality issues

  • 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

  • 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

  • Supports site Quality Management System (QMS) by acting as process owner for quality inspection document control procedures, work instructions and forms. Performs annual document reviews to ensure the content within the documents remain appropriate.

  • Provide support during regulatory and customer audits for ISO 13485 and 21 CFR 820,

  • Escalate quality problems as necessary per the applicable procedures.

  • Provide direction on difficult GDT requirements and other dimensional requirements.

  • Follow Earned Standard Hour (ESH) model for order planning and capacity planning.

  • Manages production budget to adhere to overtime, labor, and materials requirements.

  • Utilizes knowledge of continuous improvement concepts to improve plant efficiency and productivity. Uses A3 process.

  • Reports department metrics daily on Gemba walk; prepares report for daily Gemba; participates in Gemba walks.

  • Approves employee timecards daily and weekly, fixing any mistakes as needed.

  • Reviews, approves and communicates incoming employee time off requests in a timely manner.

  • Addresses employee issues; escalates or redirects them as needed.

  • Administers annual employee reviews.

  • Keeps the site Quality Manager promptly and fully informed of all problems or unusual matters of significance.

  • Coordinates and monitor workflow through the department to ensure that established task times are met; escalate issues that need to be addressed by other departments.

  • Develops employee performance development plans and provides guidance, coaching and mentorship as appropriate to ensure the team is successful in supporting plant objectives.

  • Develops and implement procedures and ensure they are being followed.

  • Establishes or adjust work priorities to meet production schedules.

  • Runs daily (weekly) team lead meetings; run weekly update meetings with team.

  • Places work order for machine repairs; tracks progress and reports to leadership.

  • Moves work and creates production gaps as required for maintenance to be able to do repairs or PMs.

  • Leads safety by complying with all safety procedures and promoting the health and welfare of all team members.

  • Ensure team members have the required knowledge and skills prior to performing job duties independently, including conducting, documenting and evaluating training effectiveness. Oversees the training of new employees on standard work instructions and policy/procedures.

  • Perform other duties as required or directed.

EDUCATION QUALIFICATIONS

  • High School Or Equivalent (Required)

  • Bachelor (Preferred)

EXPERIENCE QUALIFICATIONS

  • Experience in a FDA Regulated Environment (Required)

  • 3+ Years of Experience in a Quality Role in a Manufacturing Environment (Required)

  • 3+ Years of experience leading a team of 5+ people (Required)

  • Experience Leading Internal Quality Audits (Preferred)

  • Experience in Medical Device Manufacturing (Preferred)

  • 5+ Years of Experience in a Manufacturing Environment (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

  • Problem Solving - Working Experience

  • Quality Management - Extensive Experience

  • Manufacturing Regulatory Environment - Extensive Experience

  • Data Analysis Tools - Working Experience

  • Leadership - Working Experience

  • Computer Knowledge - Basic Knowledge

  • Communication - Working Experience

  • Interpersonal Communication - Basic Knowledge

  • Decision Making and Critical Thinking - 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 - Frequently

  • Must be able to communicate and exchange information with others - Frequently

  • Must be able to distinguish and detect information such as writing and defects - Frequently

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.